January 2018

Comparison the effectiveness of corticosteroid and pulsed radiofrequency in chronic shoulder pain

Korgün Ökmen 1, Burcu Metin Ökmen 2

1 Department of Anesthesiology and Reanimation, 2 Department of Physical Medicine and Rehabilitation, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital, Bursa, Turkey

DOI: 10.4328/JCAM.5511 Received: 13.11.2017 Accepted: 28.11.2017 Published Online: 28.11.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 87-91

Corresponding Author: Korgün Ökmen, Department of Anesthesiology and Reanimation, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital, 16130 Bursa, Turkey. T.: +90 2242955000 F.: +90 2243605055 GSM: +905057081821 E-Mail: korgunokmen@gmail.com

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Aim: Acromioclavicular joint (ACJ) disorders are particularly common in patients with impingement syndrome. We aim to evaluate the effectiveness of corti-costeroid (CS) injections and pulsed radiofrequency (PRF) therapies applied to the Acromioclavicular joint (ACJ) and the subacromial area in the long-term in patients with impingement syndrome. Material and Method: 40 patients were analyzed in 2 different groups; CS(n=20) and PRF(n=20). Pre-treatment (W0) and post-treatment follow-ups at one (W1), four (W4), 12 (W12) and 24 weeks (W24) were carried out using Visual Analogue Scale (VAS), Shoulder Pain And Disability Index (SPADI) scores and Beck Depression Inventory (BDI) Scale tests. Results: There was a statistically significant improvement in all the evalua-tion parameters at W1, W4, W12, and W24 compared to W0 in both groups (p<0.05). The comparison of the groups with each other there was no statistically significant difference between the VAS, SPADI and BDI values at W1, W4, W12, W24 (p>0.05). Discussion: Our study results showed that CS injections and PRF therapy applied to the ACJ and subacromial area were effective during six-month follow-up in patients with chronic shoulder pain due to impingement syndrome. But statistical significance superiority to each other was not determined.

Keywords: Acromioclavicular Joint; Subacromial Area; Impingement Syndrome; Corticosteroid Injections; Pulsed Radiofrequency

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Introduction

Shoulder pain is one of the most common causes of pain in the musculoskeletal system [1]. Pain and restriction in active movements of the shoulder remarkably decreases the quality of life of patients [1]. Rotator cuff pathologies and impingement syndrome are the most common causes of shoulder pain [2]. ACJ is a small joint; however, it is an important part of the shoulder girdle complex [3]. Pain and restriction in the arm lifting and cross body movements can manifest [4]. The initial treatment of symptomatic ACJ disorders often involves conservative therapies. Physical therapy modalities, analgesics, non-steroid anti-inflammatory drugs (NSAIDs), and corticosteroid (CS) injections to the ACJ can be applied [5]. Corticosteroid injections are commonly used in the management of shoulder pain thanks to their potent anti-inflammatory effects and rapid response to injection [6]. However, the use of these injections is limited due to pain, vasovagal reactions, altered serum glucose levels, facial flushing, and systemic side effects such as osteoporosis [7]. In addition, there are some reports suggesting that CS injections should not be performed frequently due to local complications such as tendon ruptures [8]. The studies have shown that CS can reduce pain and increase the range of motion of the joint with sustainable effects in the long-term [5,9].

Pulsed radiofrequency (PRF) therapy has been reported to offer an effective and simple treatment method in the management of chronic shoulder pain, and a single session can provide pain relief for a long period, thereby, facilitating functional rehabilitation [10]. It has been considered a non-destructive therapy, which does not cause neural injury [11]. In addition, PRF has been reported to be a useful treatment option in patients who are unresponsive to conservative therapies or not suitable for surgical therapy or those who are willing to undergo non-surgical treatments for chronic shoulder pain [12]. Although there are numerous studies in the literature reporting good outcomes with PRF application to the suprascapular nerve in the management of chronic shoulder pain [13,14], no study using PRF to the subacromial area and ACJ is available. In this study, we aimed to compare the effectiveness of CS injections and PRF therapies applied to the ACJ and the subacromial area in the long-term.

Material and Method

Patient Selection

Medical charts of 65 patients who were admitted to the physical medicine and rehabilitation (PMR) and algology outpatient clinics of our hospital between January 2013 and December 2015 were retrospectively reviewed. The study protocol was approved by the institutional Ethics Committee (The decision number is 2011-KAEK-25 2016/15-03). The study was conducted in accordance with the principles of Declaration of Helsinki.

Inclusion criteria were: patients with chronic shoulder pain due to impingement syndrome (diagnosed with both clinical examination findings and Magnetic Resonance Imaging (MRI)) (for >3 months), and those aged between 18 and 60 years, also patients who respond to the diagnostic block by using 3 ml prilocaine (more than 50% reduction in VAS scores).

Exclusion criteria were: patients who received PMR, injections or PRF therapy to the shoulder area in the past one year, the presence of malignancy, radicular pain and cervical myofascial pain syndrome, history of acute trauma, previous history of fracture in the shoulder to be treated, previous surgery or metal implants to the affected shoulder, inflammatory rheumatic disease, uncontrolled arterial hypertension, metabolic syndrome, diabetes mellitus, mental retardation, use of antidepressants, and autoimmune diseases.

The present study examined 40 patients meeting the inclusion criteria were analyzed in 2 different groups; Group 1: CS (n=20) and Group 2: PRF (n=20). Pre-treatment (W0) and post-treatment follow-ups at one (W1), four (W4), 12 (W12) and 24 weeks (W24) were carried out using Visual Analogue Scale(VAS), Shoulder Pain And Disability Index (SPADI) scores and Beck Depression Inventory(BDI) Scale tests.

Treatment Protocol

All invasive procedures were performed by the same physician. On the patient who was in prone position, the C-arm fluoroscopy was adjusted toward the lateral and cephalo-caudal direction until the ACJ was identified within sight. After cleaning the access site, local anesthesia was administered to the cutaneous and subcutaneous tissue using 3 ml prilocaine. A 22 G 10 cm needle was guided to ACJ under fluoroscopy (Figure 1).

Following;

Pulsed Radiofrequency Procedure

PRF procedure was applied with 5 mm active-tip RF needle at 45 V, 200 ms, 42 0C for 120 s (2 min) ACJ and subacromial area 120 sn (2 min) (NeuroTherm, Middleton, MA, USA).

Corticosteroid Protocol

A 3-ml of the mixture of bupivacaine 0.25% (4 mL) and methylprednisolone 40 mg (1mL) was administered to the subacromial area, and a 2-ml of the mixture was administered into the ACJ. In both groups, no posttreatment complications were observed during the follow-ups.

Outcome Measures

The VAS score was used to evaluate the pain severity, the SPADI for to measure shoulder discomfort and BDI for to evaluate depression.SPADIs’ evaluation includes two parts: pain and disability. Part 1 (shoulder pain index (SPI)) includes five questions in the pain subgroup and measures the pain experienced by the patient over the previous week using VAS (0 no pain, to 10 most severe pain). Part 2(shoulder disability index (SDI)) is the disability subgroup and includes eight questions and measures the degree of difficulty (0 no difficulty, to 10, requires help) in the shoulder movements of the patient during the last week. SPADI includes 13 questions, and zero point refers to maximal well-being, and 130 points refers to maximal sickness. We evaluated each part of the SPADI; SPI, SDI, and total SPADI separately. The validity of SPADI was demonstrated [15].

The Beck depression inventory (BDI) aims to measure behavioral findings of the depression in adults and adolescents. This inventory is composed of 21 items each ranked from mild to severe disease form. The patients are asked to mark the item that best fits their situation, and the total score is calculated by the sum of scores achieved in each item. 0-13 points indicate no depression, 14-19 points indicate mild depression, 20-28 points indicate moderate depression, and 29-63 points indicate severe depression. The total score on this scale is 63 points [16].

In addition, the patients did not receive any additional analgesic agents, PMR, or another intervention during follow-up.

Statistical Analysis

Analysis of the collected data was performed using IBM SPSS 22.0 statistical package program. When the study data were evaluated, the Pearson chi square (χ2) or Yates χ2 tests were used in the comparison of the qualitative variables, in addition to descriptive statistical methods (frequency, percentage, mean and standard deviation). Normal distribution of the data was tested using Shapiro-Wilk test. Independent Samples t-test (t-test for independent groups) was used in between-groups comparisons while variables were found normally distributed. When a normal distribution was not found, the Wilcoxon signed rank test for group comparisons and Mann Whitney U test for comparisons between groups were used. Variance analysis with repeated measurement (ANOVA) was used in in-group comparisons. Values with a probability of (P) α<0.05 was accepted as significant.

Results

Of 40 patients, 14 were males, and 26 were females. There was no statistically significant difference between the two groups concerning age, gender, body mass index (BMI), duration of pain, side and week 0 (W0) values of VAS, SPI, SDI, SPADI and BDI (p<0.05) (Table 1). There was a statistically significant improvement in all the evaluation parameters at W1, W4, W12, and W24 compared to W0 in both groups (p<0.05) (Table 2).

The comparison of the groups with each other there was no statistically significant difference between the VAS, SPI, SDI, SPADI and BDI values at W1, W4, W12, W24 (p>0.05) (Table 2).

Discussion

Although the present study showed significantly successful outcomes with both procedures, compared to baseline values, there was no statistically significant difference in the outcomes at W0, W1, W4, W12, and W24 follow-up visits between the two groups.

Impingement syndrome accounts for 44 to 65% of patients with chronic shoulder pain [17]. Initial therapy in impingement syndrome involves a conservative approach, whereas CS injections are commonly used [5]. Many studies have attempted to reveal the efficacy of CS injections commonly used in the management of chronic shoulder pain [18,19]. Among these studies, Göksu et al. included 61 patients in their study in which one group received triamcinolone acetonide + bupivacaine injection to the subacromial area, while the other group received Kinesio-taping three times with three days off [19]. The patients were assessed using the VAS, Passive range of motion (PROM), and SPADI. The authors found a statistically significant difference in the efficacy of CS injections at 4 weeks after therapy. Similarly, another study evaluated the outcomes of CS injections to the subacromial area under the guidance of ultrasonography, and the authors reported that this approach was effective in the short-term at 6 weeks during follow-up [18].

Furthermore, several studies have addressed possible local and systemic side effects of CS injections to the subacromial area [7,20,21]. In a study, Hong et al. showed no statistically significant difference between 20 mg and 40 mg doses and concluded that preferred use of a low dose at the initial stage [20]. In another study, 40 patients were divided into two groups: Group 1 received tenoxicam injections to the subacromial area once weekly for three weeks, and Group 2 received a single dose of methylprednisolone to the subacromial area.Both groups showed that these therapies were effective. However, the authors recommended tenoxicam as the first-line therapy thanks to its superior safety profile [21]. In the present study, patients who were considered to have a higher risk due to side effects of CS were excluded, and patients included in the study received a single CS injection.

Often subacromial area is evaluated in the impingement syndrome, and the therapy is directed to this area. It has been reported that rotator cuff problems can be avoided if ACJ OA is treated in the early period. In the study by Hossain et al. which evaluated the efficacy of CS injections to the ACJ, 25 patients with primary ACJ OA received intra-articular CS injections and were followed for five years [9]. The authors reported that CS injections in the treatment of primary isolated ACJ OA had prolonged effects sustaining up to 12 months. In another study, 58 patients with isolated ACJ symptoms received lidocaine + CS injection. In the study above, favorable outcomes at one month were observed in 28% of the patients. The patients who benefited from the injections were also followed for 42 months, and favorable outcomes were sustained in the long-term in most cases [5]. The present study attempted to increase the efficacy of therapy using injections to the subacromial area and ACJ in patients with chronic shoulder pain due to impingement syndrome.

Furthermore, as a novel treatment modality, PRF therapy is commonly used in the management of pain in today’s practice. It is a non-neurolytic, effective, and easily applicable method which offers long-term relief with a single session of therapy [10,11]. This type of therapy to the nerves has also been reported to stimulate nociceptive nerve endings and, thereby, prolonged depression in the first synapses. In addition, PRF therapy has been suggested to increase the production of anti-inflammatory cytokines by producing an electric field on the immune cells, and progression of this process is regulated by increasing levels of pro-inflammatory cytokines such as interleukin (IL)-1b, tumor necrosis factor-alpha (TNF-α), and IL-6 [8]. However, intra-articular use of PRF therapy in pain management is limited to case reports in the literature [8,22]. In a report of three cases who received therapy to the glenohumeral joint, Ozyuvaci et al. reported PRF therapy as a recommendable treatment modality [22].

In addition, PRF studies in the management of chronic shoulder pain often evaluated the application to the suprascapular nerve rather than application into and around the joints [14,23]. In a series of 40 patients who received PRF therapy to the suprascapular nerve due to impingement syndrome, the patients were evaluated using the Likert scale and Oxford Shoulder Score for six months, and it was found to be an effective treatment modality and the effects of this therapy were sustained in the long term [14]. In another study including 57 patients with chronic shoulder pain resistant to medical treatment, PRF was applied to the suprascapular nerve for 480 seconds, indicating a statistically significant recovery during follow-up [23].

Moreover, in a randomized controlled trial carried out by Gofeld et al. in 22 patients with chronic shoulder pain, the first group received lidocaine and the second group received lidocaine + PRF therapy to the suprascapular nerve during a six-month follow-up [24]. The authors reported significantly better outcomes in the PRF group. Another study which induced lesion using PRF to the suprascapular nerve under fluoroscopy in 13 patients with chronic shoulder pain showed that this therapy could be a potential treatment option in patients suffering from chronic shoulder pain, provided long-term pain control, and reduced the amount of analgesics [25].

In the present study, PRF therapy was applied to the subacromial area and ACJ. The success of the present study can be attributed to the effects of therapy on nerve endings in the ACJ and subacromial area. The discussion in this manuscript was limited due to lack of studies in the literature that evaluated the application of this therapy to the subacromial area and ACJ.

Limitation

Small sample size and lack of a placebo group were the main limitations of the present study.

Conclusion

In conclusion, our study results showed that CS injections and PRF therapy applied to the ACJ and subacromial area were effective during six- month follow-up in patients with chronic shoulder pain due to impingement syndrome. But statistical significance superiority to each other was not determined.

Scientiﬁc Responsibility Statement

The authors declare that they are responsible for the article’s scientiﬁc content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientiﬁc review of the contents and approval of the ﬁnal version of the article.

Animal and human rights statement

All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

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Korgün Ökmen, Burcu Metin Ökmen. Comparison The Effectiveness Of Corticosteroid And Pulsed Radiofrequency In Chronic Shoulder Pain. J Clin Anal Med. 2018;9(1):87-91

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Comparison stage of vaginal delivery in painless labor with epidural & spinal analgesia

Alireza Kamali 1, Samane Akbari 1, Afsane Norouzi 1, Maryam Shokrpour 2

1 Department of Anesthesiology, 2 Department of Gynecology, Arak University of Medical Sciences, Arak, Iran

DOI: 10.4328/JCAM.5489 Received: 08.11.2017 Accepted: 08.11.2017 Published Online: 10.12.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 82-6

Corresponding Author: Maryam Shokrpour, Maryam Shokrpour, Department of Gynecology, Arak University of Medical Sciences, Arak, Iran.T.: 00989053634212 F.: 00982153634213 E-Mail: Maryam_shokrpour@yahoo.com

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Aim: Aim of this study was comparison stage of vaginal delivery in painless labor with epidural &spinal analgesia. Material and Method: This study was clinical trials and double blind.90 pregnant women in Taleghani hospital entered in this study. We divided women in 3 groups (spinal analgesia, Epidural analgesia, control) randomly. We recorded Heart rate and blood pressure and oxygen saturation in mothers every 15 minutes and fetal heart rate and apgar in one and five minute after delivery and dilatation in cervix every 2 hours for full dilatation. Results: Mean of second stage in delivery in control group was less than others groups (p=0/01).In Epidural and spinal groups were not significant difference (P> 0/05). Discussion: Mean of second delivery in epidural and spinal analgesia decreased.

Keywords: Epidural; Spinal; Painless Labour; Vaginal Delivery Stage

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Introduction

Labor is a complicated mental experience. Various factors affect a women’s perception of labor which makes any experience unique. However, the labor pain is classified as the most severe pains in the pain ranking scale compared to the other painful life experiences [1].

The labor pain is one of the most challenging experiences with which women face in their life. The painful labor causes physiological changes which may threaten the health of the mother and the baby [2]. Although the pain level experienced by a parturient depends on many factors such as the amount of using Oxytocin, dysfunctional labor, delivery phases duration, and even psychological issues, an ideal analgesia can be provided to relieve pain through different delivery phases such that it can satisfy the parturient needs [3]. Regarding the increased cesarean rate in Iran, the World Health Organization recommendation to decrease cesarean and increase normal delivery, and the new policies of population growth in the country, some plans were adopted to support normal delivery. Hence, the anesthesia specialists helped the gynecologists and midwives and presented different analgesia methods. Therefore, it is of the mothers’ rights to have an analgesia delivery [2, 3, and 4]. The analgesic delivery should be secure and have the minimum unwanted consequences for the mother, baby, and the delivery procedure [4]. Neuraxial analgesia techniques are among the methods used in the today’s modern world which seeks the high satisfaction level of the mothers and a desirable effectiveness; these techniques have been accepted as the most effective methods for pain relief with the minimal side effects and high quality in the last recent decades [3]. Different kinds of interventions have been carried out in the two last decades to achieve this goal; the interventions included using low doses of local anesthetics/ narcotic mixture, combined spinal and epidural anesthesia (CSE), patient-controlled epidural analgesia (PCEA), and spinal analgesia [5]. The modern neuraxial analgesia in the delivery procedure indicates a shift in the anesthesia field of Obstetrics and Gynecology since it changes the attitude from a simple concentration in the pain reduction to concentration in the overall quality of analgesia [6].

Nowadays, in many of the countries, the regional analgesia for delivery is considered as a reflection of the standard delivery cares [7]. About 60% of the women in the United States of America receive a kind of neuraxial analgesia. However, there is a concern regarding the negative impact of these methods on the delivery and delivery procedure [8]. Although the advantages of using these methods are known, there are controversies regarding their consequences [2]. The controversies indicate that these methods cause the increased cesarean rate, the increased need for forceps delivery, the increased delivery phases, and the increased need for Oxytocin. However, the prospective studies which have been recently done violate these results. In fact, one of the main reasons for the patients’ refusal of neuraxial analgesia is its intervention with delivery phase and result [2]. In spite of these controversies, the rate of using these techniques is increasing. In Iran, these methods have been not completely used because of the concern regarding the analgesia impacts on the mother and the baby. Some studies have been conducted regarding pain control and pain reduction methods in the recent years. Some have indicated that the epidural anesthesia increases the whole delivery period and phases [9 and 10]. Moreover, some studies have indicated that the duration of the active phase is shortened [11 and 12]. Besides, some studies have also concluded that there is no significant difference between delivery and vaginal delivery in terms of duration [13 and 14]. Some papers have preferred the spinal method to the epidural one [15]. With regard to these disagreements, the researchers decided to conduct a study to compare the delivery phases in the two spinal and epidural methods.

Material and Method

This study is a randomized clinical trial which was double blindly conducted on all pregnant women visiting Arak Taleqani hospital; they were candidates for having a natural delivery. In this study, about 90 pregnant women who were candidates for having a natural delivery, had the inclusion criteria, and had the informed consent to participate in analgesic delivery were investigated as the population of the study. The nulligravida, primigravida, single birth, and 37-42 gestational age mothers had the inclusion criteria. They completed the informed consent form and were randomly divided into three equal groups using cubal Randomized: epidural analgesic delivery, analgesic delivery with spinal analgesia, and the control group which lacked any labor and pain. After doing hemodynamic recording, complete monitoring, fetal heart rate recording, the embryo health status assurance, and the mother’s hemodynamic stability assurance, all patients went into normal vaginal delivery (NVD). In the first group, 30 pregnant mothers went under analgesia after a complete monitoring, taking the appropriate IV, and receiving the liquid (about 200-300 cc) in the seated stance by 4-6 cc of the 0.125 Marcaine in addition to 25 microgram Fentanyl that the desirable injection volume reached 10 ccs. It was done in an L4-L5 or L3-L4 space by the G20 epidural needle made by the German Bibrun company (in single shout). Then, the epidural catheter was fixed for the patients. The maintenance dose of the drug was about 6-10 cc of the 0.0002-percent Marcaine which was injected through the catheter. In the second group, 30 patients went under spinal analgesia in the seated stance, having the inclusion criteria, by the G25 needle made by the German Bibrun company in an L4-L5 or L5-S1 space, and with 50-75 microgram Fentanyl whose volume had reached to 2 ccs by distilled water. In the third group, 30 pregnant mothers had the inclusion criteria, were considered as the control group, and received no analgesic delivery method. Finally, the control-group mothers were put in a supine stance after doing the said blocks. Then, they were gone under normal vaginal delivery. The anesthesia technician monitored the mothers’ vaginal delivery in the whole process and the vital signs including heart beats, the percentage of oxygen saturation, blood pressure, and also the fetal heart rate were recorded every 15 minutes. The intern partner for midwife precisely examined and recorded the delivery phases and times for cervical examinations per minute in terms of delivery progression in every 2 hours until full dilatation and delivery. Besides, in addition to the labor phase time, the mothers’ vital signs, fetal heart rate, and Apgar were also recorded in the project questionnaires. The results of the aforementioned questionnaires were gone under statistical analysis via SPSS 19. Finally, the data were presented as statistical tables and figures. The study was conducted in a double-blind procedure and this was confirmed since the intern partner was responsible for completing the project questionnaires and the person who was responsible for the project statistical analysis was completely unaware of the study procedure and the studied groups. The anesthesiologist prepared the drugs and gave to the resident who performed the analgesic labor (spinal and epidural analgesia). The project intern partner who was responsible for complete the questionnaires as well as the person who was responsible for doing statistical analysis were blind toward the studied groups. The pregnant mothers who were willing to participate in the project were completely randomly divided into spinal and epidural groups. The placebo group also included all mothers who were reluctant to go under analgesic labor (the mothers who were included in the project were also blind regarding the studied groups because the mothers who go under analgesic labor are separately treated in another room away from the mothers who would not experience analgesic labor).

-The Inclusion Criteria

1. All pregnant mothers who are in their 37-42 weeks of pregnancy.

2. Mothers whose completely informed consent to participate in the project has been confirmed.

3. All ASA mothers with class 1 and 2

4. The primigravida mothers

5. Single birth pregnancy

6. All mothers for whom the cervical dilation would be 3-4 centimeters at the beginning of the labor.

7. The lack of a systemic infection or fever and other ground diseases

8. Insensitivity to LA and narcotics

9. The absence of coagulopathy

10. Mothers with 18-40 years old

-The Exclusion Criteria

1. The lack of the informed consent for participating in the project

2. Class 2 and 3 of ASA

3. All patients for whom the epidural and spinal analgesia have been unsuccessful.

4. Patients sensitive to LA and narcotics

5. Mothers with a gestational age lower than 37 weeks

6. Mothers who are not primigravida.

7. Mothers with more than one fetus

A phase is randomly easy.

To be more precise, 30 people are put in each group instead of 28 people. Therefore, n=90.

Results

Regarding [table 1], there was not a significant difference among the three groups in terms of age and the age average of the three groups was nearly 26 years old (P ≥ 0.05).

There was not a significant difference among the three groups of epidural analgesia, spinal analgesia, and the non-analgesic delivery group in terms of the first phase delivery means (P≥ 0.05). However, as [table 2] shows, there was a significant difference among the said three groups in terms of the second phase delivery mean. The second phase delivery mean was significantly lower in the non-analgesic delivery group compared to the other two groups (P=0.01). There was not a significant difference between epidural analgesia and spinal analgesia groups in terms of the second phase delivery (P≥ 0.05).

As [table 3] indicates, there was not a significant difference among the three groups of epidural analgesia, spinal analgesia, and the non-analgesic delivery group in terms of the babies’ Apgar means at 1 minute (P≥ 0.05). Besides, there was not a significant difference among the three groups in terms of the babies’ Apgar means at 5 minutes (P≥ 0.05).

The gestational age means of the pregnant mothers in the three groups were almost equal and there was not a significant difference (P ≥ 0.05). Nearly, the gestational age means in the three groups was 39.8 weeks [table 4].

According to [table 5], there was not a significant difference in comparing the side effects of dizziness, headache, and backache in the three groups of epidural analgesia, spinal analgesia, and the non-analgesic delivery group (P ≥ 0.05). However, there was a significant difference between the three groups in terms of the side effects of nausea and vomiting such that nausea and vomiting were more in the spinal group than the other two groups (P=0.01).

Discussion

Achieving the difference between the delivery phase means in the various kinds of analgesic labor methods helps to optimally use these methods and more desirably control the labor pain. On the other hand, it is of importance to know the fact that whether using analgesic labor control methods leads to an increase in the delivery duration or not. It has been the major objective in the similar studies and can be a document for optimally using these methods. In the present study, the comparison of the delivery time means significantly showed that the second delivery phase duration means in the control group (the group which did not receive the analgesic delivery) was lower than the two groups of epidural and spinal. Besides, there was not a significant difference between the analgesic delivery groups (epidural and spinal) and the control group in the first delivery phase. In other words, using the analgesic delivery methods (epidural and spinal) not only does not increase the first delivery phase duration but also there is not a significant difference between this phase and the control group in terms of the delivery duration mean. The results of this study are nearly the same as and close to the ones obtained in the previous similar studies. Dr. Kamali, et al. (2016) conducted a study on comparing delivery phases in the analgesic delivery through the two methods of epidural analgesia and Entonox, indicating that the delivery phase duration mean (phases 1 and 2) in the two groups of epidural analgesia and Entonox was lower than that of the control group. Furthermore, in comparing the two groups of epidural analgesia and Entonox, it was shown that the delivery phase mean in the epidural group was higher than Entonox group [16]. A study was conducted in Qazvin, Iran (2002) and it was indicated that the epidural analgesic delivery shortens the delivery active phase while increases the second delivery phase compared to the normal delivery. Moreover, this study indicated that the caesarean prevalence in the two groups (epidural and control) was the same and they had similar baby Apgar [17]. The results of the abovementioned study were consistent with the present study because the second delivery phase mean of the epidural group was more than the control group in this study. Another study was conducted in India (2011-2014) on 120 nulligravida women and it was indicated that the first delivery phase duration in the epidural group was shorter than the control group, but the second delivery phase duration in the epidural group had increased compared to the control group. The rate of caesarean and delivery with aids had not increased in the epidural group and the Apgar at 5 minutes was similar in the two groups [18]. Another study was also done in Hamadan, Iran (2011) on 200 pregnant women and it was indicated that there is not a significant difference between the spinal and control group in terms of the first and second delivery phase duration. The results of this study were consistent with those of the present study, but the present study indicated that the second delivery phase in the analgesic delivery (epidural and spinal) had increased compared to the control group [14].

Lolaee and Teymouri (2011) conducted another study in Najmieh hospital, Tehran, and showed that there is not a significant difference between the different delivery phase times among the control, epidural, and spinal groups [19]. However, some of the available resources and studies have indicated that using regional analgesia in analgesic delivery prolongs the delivery procedure. The prospective study was carried out in Guangzhou, China (2011) by Zhang. It was indicated that the first phase, the second phase and the overall delivery duration in the epidural group had increased compared to the control group [20]. Undoubtedly, the normal delivery is severely painful; in McGill Pain Diagram (MCGILL) which was developed in 1990, it was made clear that after Causalgia (NEUROLEPTIC PAIN), the labor pain has a high score compared to other pains like fractures, cuts, and chronic backache. Therefore, it seems necessary to create a condition of comfort and analgesia during the labor so as to encourage the mothers to go under normal delivery and reduce the pregnant mothers’ willingness to caesarean. The labor pain is one of the most important challenges a mother faces in her life. A painful delivery experience is the worst medical memory she would have in her life such that this experience causes the patients’ severe fear of normal delivery and willingness to caesarean. During the painful physiologic delivery, a great amount of Epinephrine and Norepinephrine is released in the circulatory system in response to the mother’s pain that causes various side effects including the increased mother’s PR, excessive use of oxygen, and reduced blood supply to the fetus. Besides, the labor pain causes the pregnant mothers’ hyperventilation, hypocapnia (reduced CO2), acid-base disorders, and finally insufficient reception of oxygen by the baby. All the above items can be controlled and eliminated by an effective analgesic delivery. Using the two methods of epidural analgesia and spinal analgesia is completely effective in controlling labor pain in the first and second delivery phases. As it is known, segments T10 to L1 are responsible for innervating the dermatomes related to the first delivery phase and segments S2 to S4 are responsible for innervating the second delivery phase. The recent studies indicate that the two epidural and spinal methods are effective in controlling pain in the two delivery phases. The studies conducted by the present researchers indicated that the patients in the two epidural and spinal methods were equally satisfied. The special regional techniques by epidural analgesia are very effective and flexible and have little side effects. This study indicated that the epidural and spinal analgesic delivery do not have a significant effect on the babies’ health and Apgar at the 1 and 5 minutes and the Apgar at 5 minutes was 10 in the three groups. Furthermore, there was not a great difference in the three control, epidural, and spinal groups in terms of caesarean prevalence. However, according to some studies, the caesarean prevalence in the mothers who had used the analgesic delivery methods was more than the control group. Regarding the side effects of the pain control methods during labor, hypotension and bradycardia were the only side effects which were observed in the analgesic delivery group and only happened at 15 to 20 percent of the basic level; however, there was no special side effect caused by the analgesic delivery methods in the said mothers. Regarding the previous studies and the results of this study, it can be said that using the analgesic delivery methods leads to the mothers’ comfort and satisfaction during labor; this is an effectively important factor in reducing the mothers’ willingness to go under caesarean and surgery. In fact, the pregnant mothers’ satisfaction during labor is a very important factor which plays a significant role in reducing the rate of caesarean in different societies. In this study, the mothers’ satisfaction in epidural and spinal groups was clearly more than the mothers in the control group and there was not a significant difference between the two epidural and spinal groups. Anyway, it seems necessary that conducting similar studies with more participants is an essential and inevitable issue so as to develop the epidural and spinal analgesic delivery so that the results of this study can be generalized to other societies.

Scientiﬁc Responsibility Statement

Animal and human rights statement

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

References

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Alireza Kamali, Samane Akbari, Afsane Norouzi, Maryam Shokrpour. Comparison stage of vaginal delivery in painless labor with epidural & spinal analgesia. J Clin Anal Med. 2018;9(1):82-86

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Mini open surgical treatment of knee septic arthritis with local anesthesia: a prospective preliminary report

Mehmet Fethi Ceylan 1, Savas Guner 2, Ugur Turktas 2, Levent Ediz 3, Ugur Goktas 4, Ali Dogan 2

1 Department of Orthopedics, Medical Faculty, Inonu University, Malatya, 2 Department of Orthopedics, Medical Faculty, Yuzuncu Yıl University, Van, 3 Department of Physical Medicine and Rehabilitation, Medical Faculty, Yuzuncu Yıl University, Van, 4 Department of Anesthesia and Reanimation, Medical Faculty, Yuzuncu Yıl University, Van, Turkey

DOI: 10.4328/JCAM.5461 Received: 01.11.2017 Accepted: 09.12.2017 Published Online: 01.01.2018 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 77-81

Corresponding Author: Mehmet Fethi Ceylan, Department of Orthopedics, Inonu University, Medical Faculty, 44280, Malatya, Turkey. GSM: +905359524440 F.: +90 4223410728 E-Mail: mfethiceylan@hotmail.com

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Abstract

Aim: Good pain management is provided via spinal and general anesthesia during knee joint drainage to treat septic arthritis, but the side effects are greater than those associated with local anesthesia, and the preparation process is long. Arthroscopic drainage under local anesthesia for knee septic arthritis treat-ment have been described, but this method requires special equipment. In this study, we aimed to evaluate the applicability of mini-open surgery under local anesthetic infiltration in cases of septic knee arthritis. Material and Method: 14 consecutive patients (eight men, six women) were admitted for knee septic arthritis treatment. Patient age ranged from 18 to 56 years, with an average age of 33 years. Drainage procedure was performed under local anesthesia, and the results were evaluated clinically. Results: The visual analog scale scores were between two and four (mean 2.8). The follow-up period was 10-21 months (mean 14.3). The Tegner and International Knee Documentation Committee scores were acceptable except for one patient. Discussion: This prospective study included mini-open surgery performed under local anesthesia on 14 septic knees, and showed that this method is safe, effective, well tolerated and be alterna-tive to conventional techniques.

Keywords: Knee Joint; Septic Arthritis; Local Anesthesia; Mini-Open Surgery

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Introduction

Surgical drainage is the most effective treatment for septic arthritis [1]. Knee septic arthritis drainage is performed with local, regional and general anesthesia. The use of local anesthesia rather than general or spinal anesthesia has several advantages. For example, there is no need for an anesthetist, it simplifies postsurgical patient management [2], and it eliminates the need to fasting for at least a few hours [3,4]. This last point is important because any delay in administering treatment for septic arthritis can affect prognosis [5]. In addition, regional and general anesthesia has more complications than the local anesthesia.

Local anesthesia for arthroscopic knee intervention is a well-documented treatment, but this method requires specialized arthroscopic equipment [6-9]. In addition, insufficient sterilization of contaminating equipment can lead to infection during subsequent operations [10].

There is no literature in English regarding drainage of the septic arthritis of the knee using the mini-open technique. In this study, we aimed to evaluate the applicability of mini-open surgery under local anesthetic infiltration in cases of septic knee arthritis. The present study aimed to report the results of a prospective study of 14 consecutive mini open-surgeries to drain septic knees conducted under local anesthesia.

Material and Method

The study was approved by our university’s ethical committee, and all patients gave their informed consent prior to their inclusion in the study. Fourteen consecutive and compatible patients (eight men, six women) age ranged from 18 to 66 years were admitted for septic knee arthritis treatment. Inclusion criteria were patients who had the complaint fewer than for five days. Exclusion criteria were the allergy to local anesthetic agents or non-steroidal anti-inflammatory drugs, in cases where local anesthesia can not be tolerated, and presence of metaphyseal osteomyelitis. Patients younger than 18 years were also excluded.

Diagnosis of septic arthritis was made with clinical examination, and laboratory tests, including leukocyte number, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) values, joint ultrasonography, and magnetic resonance imaging in some patients but mainly as a result of the evaluation of the sample obtained by joint aspiration. Direct examination of the sample under a microscope, the presence of bacteria or the determination of polymorphonuclear leukocytes more than 90% was regarded as sufficient for the diagnosis [11-12].

After the intraoperative sample was collected, empirical therapy was initiated as intravenous cefazolin, and it was changed as needed according to the culture results. Antibiotic therapy was given parenterally to all patients for 4 weeks, then orally for 2 weeks. Treatment effectiveness was clinically evaluated by assessing reductions in local pain, temperature, effusion and redness of the knee. Leukocyte, ESR, and CRP values were also measured. When improvement was detected in clinical and laboratory findings, the patients were instructed to begin active and passive motion intervals of the knee joint and were mobilized with crutches.

Surgical preparation and application

The same surgeon (MFC) marked an approximately 2-3 cm incision line on the skin with an indelible pen (Figure 1). A mixture of 2% prilocaine (10 mL) and 0.5% bupivacaine (10 mL) in a 1:1 ratio was used for local anesthesia, and then, an intravenous cannula was inserted to administer 0.25 mL/kg. Next, the surgeon infiltrated anesthetic agent from the skin to the synovium at previously marked sites at least five minutes before operation. The patient was observed to pulse and blood pressure. After infiltration of local anesthesia, efficacy was assessed with hot-cold and pinprick susceptibility tests. A tourniquet was not used for all patients.

An anterolateral parapatellar incision was used on all of the patients, and then, the surgeon performed a mini capsular incision to enter the joint. The purulent fluid was drained after a sample was taken. The joint was then washed with 6-8 L of saline. Visible articular cartilage was evaluated (Figure 2) before the aspirative drain was placed in the joint, and the tissues were properly sutured. The aspirative drain was kept in place for at least 48 hours after surgery and was removed when the drainage fell below 30 mL/day.

Clinical evaluation

We recorded following information about the patients: ages, gender, fasting periods at admission, accompanying systemic diseases, antibiotic use, how many days they had complaints during the application, gram staining and culture results, possible disease etiology and recurrence rates.

The acceptability of the technique and the quality of intra-operative local anesthesia were assessed using a 10-cm visual analog scale (VAS), with zero and ten labeled as ‘no pain’ and the ‘worst pain’ imaginable, respectively. The pain that the patient felt while the surgical procedures were performed was questioned on the first postoperative day. VAS pain score was not reassessed in patients who underwent subsequent treatment for recurrence. The treatment outcome was determined before surgery and at the final follow up using the Tegner Activity Level (TAL) scale and the International Knee Documentation Committee (IKDC) grading system[13,14].

Statistical method

Descriptive statistics were presented as the mean s±standard deviation, minimum and maximum values for the continuous variables (characteristics) while frequency and percent for categorical variables. Likelihood Ratio Chi-Square test was also performed to determine relationships between categorical variables. Statistical significance levels were considered as 5%, and SPSS 13 statistical program was used for all statistical computations.

Results

Data on the 14 patients who developed septic arthritis are listed in Table 1.

Three patients had controlled type 1 diabetes, and one had undergone hemodialysis for five years due to chronic renal failure. When the patients were diagnosed with septic arthritis, the fasting period was longer than six hours in just three patients (21%).

The mean number of leukocytes at diagnosis was 12.2×103±1.4×103/µL (between 11×103 and 16×103/µL, the normal value is 4×103 to 10×103/µL). The mean ESR was 64±31.6 mm/h (between 20 and 116 mm/h, normal value <20 mm/h), and the mean CRP level was 82±30.1 mg/L (between 53 and 177 mg/L, normal value <5 mg/L).

None of our patients developed complications due to the local anesthesia. The average VAS value was 2.8 (between 2 and 4). The postoperative period was managed with intravenous paracetamol, and there was no need for narcotic analgesics in any patients.

Re-washing was performed under local anesthesia for three of the patients (21%) within the first week after the surgery due to a lack of improvement in clinical and laboratory parameters. None of these patients showed evidence of pathogenic microorganisms in the first culture isolate. Notably, one was diabetics, and one was a hemodialysis patient. Three months after intervention, ESR and CRP values were within normal ranges in all patients.

Just one patient experienced pain and knee movement limitation; this was the hemodialysis patient who underwent a second procedure. Although X-ray did not reveal any degeneration, his knee flexion was limited up to 20 degrees, and he felt pain during flexion over 100 degrees. IKDC and TAL values determined in the last follow-up were significantly found better than before surgery (P<0.05). Table 2 shows subjective TAL and IKDC grades for all patients.

Discussion

The knee joint is the most common site of septic arthritis [15]. Joint contamination is usually the result of hematogenous bacterial infection, and similarly, it can also occur following surgery, joint injection or trauma [16-18]. Half of the patients who were included in this study had hematogenous septic arthritis.

The septic arthritis of the knee joint is diagnosed with the help of clinical, laboratory, and radiological evidence [1]. The most common symptoms are systemic high fever, pain, effusion, skin redness, movement limitation and increased temperature of the joint. Elevated acute phase reactants, determination of bacteria in the gram stain of the sample taken from the joint, or increased levels of polymorphonuclear leukocytes may help the diagnosis. The culture of the sample obtained from the joint fluid by puncture is necessary to identify the pathogen in the diagnosis of septic arthritis and to determine which antibiotics to administer [1,19]. The absence of bacterial proliferation in the sample obtained from the joint fluid does not exclude a diagnosis of septic arthritis. In patients with negative gram stain results, the detection of bacteria or more than 90% polymorphonuclear leukocytes was sufficient for diagnosis [11]. The present literature reports low rates of 18-48% for culture-negative septic arthritis [20]. Reproduction in culture was detected in four of our cases (28.6%), and this low rate was associated with broad-spectrum antibiotic use before applying for emergency department in half of the patients.

It has been suggested that the most important prognostic factor for septic arthritis was the time elapsed between symptom onset and surgical treatment. Complications that develop as a result of septic arthritis are serious conditions, such as cartilage damage, osteomyelitis, avascular necrosis, septic dislocation and sepsis [11]. According to the literature, cases are considered to have delayed treatment if symptoms have manifested for more than four days [5]. It has been emphasized that joint damage can be prevented with proper surgical drainage and antibiotic treatment following timely diagnosis of acute septic arthritis [21]. In our series, the average time from the start of complaints to surgical intervention was less than four days (2.9), and we achieved good outcomes.

A fasting period is necessary for general or regional anesthesia. If emergency surgical drainage is performed for patients who do not have a sufficient fasting period, serious complications may develop due to aspiration of gastric content [3,4]. Accordingly, surgical treatment of the patients under regional or general anesthesia may be delayed due to an insufficient fasting period. In this study, only 21% of the patients had a fasting period of more than six hours. This method, which can be applied with local anesthesia, is the most important advantage over other methods in that it does not require fasting time.

Joint drainage and washing are the basic surgical procedures in the treatment of septic knee arthritis. These processes can be performed arthroscopically, open surgery, and needle aspiration. The final method is conservative, and its effectiveness is lower than both types of surgical procedures [22]. During intervention, general, regional or local anesthesia may be preferred by the patient. While these methods are comparable to each other, treatment efficacy, patient pain tolerance, and anesthesia complications are taken into consideration when making a selection [6]. Local anesthesia was found effective because pain tolerance is good, the joint can be washed adequately and the anesthesia risk is low.

Spinal and general anesthesia during intervention to treat knee disorders provides better pain control, but the side effects are more serious than local anesthesia, and it has a long preparation process. In addition, local anesthesia cost is low, and the patient remains awake in this method [6,23,24]. However, it cannot be used in children and incompatible adult patients. If the patient’s ASA score increases complications also increase in the surgery [25]. Intervention with local anesthesia is more advantageous for patients with a high ASA score. In this study, the score of four patients was higher than 2, and no complication was encountered.

Septic arthritis surgery performed under local anesthesia; while it is a safe method, it is necessary to be careful regarding possible side effects, such as cardiac toxicity, methemoglobinemia and allergic reactions [26-28]. The total local anesthetic amounts given to the patients in our study did not exceed the recommended [29] maximum safe dose of 2 mg/kg for bupivacaine and 7 mg/kg for prilocaine, and no side effects were observed.

Many studies have previously reported successful results regarding the surgical treatment of septic knee arthritis arthroscopically [30-32]. However, under local anesthesia, there are few studies in which this procedure is applied [33]. There are advantages of this method, such as a lack of adverse effects associated with regional and general anesthesia, performing debridement while visualizing the joint, economic benefits and less tissue damage compared to open surgery [23,33]. But this method is not suitable for the presence of associated metaphyseal osteomyelitis. However, this method requires special arthroscopy equipment.

Iatrogenic infection resulting from arthroscopy is an increasingly frequent source of septic arthritis. In general, the risk of procedure-related septic arthritis has been estimated at 0.15-4.2% for arthroscopies [34-36]. In 70 ligament reconstruction surgeries performed by Viola et al., infection was detected in 10 patients, and they found that the origin of contamination (coagulase-negative Staphylococcus) was the supposedly sterile inflow cannula. When they changed this device, they had only one infection in the next 400 reconstructions [10]. Similarly, Blevins et al. found that the cannulas used after the arthroscopic meniscus repair caused infection in three patients [37]. Parada et al. detected the instrumentation-specific infection after the anterior cruciate ligament reconstruction [38]. It has been reported that septic arthritis following knee arthroscopy could result in malpractice litigation [39]. For these reasons, maximum attention should be paid to sterilization so that arthroscopic devices used in the surgery of septic arthritis do not cause septic arthritis in subsequent patients. We could not find any information in the literature regarding sterilization of arthroscopy equipment used in the surgical treatment of septic arthritis.

The lack of control group, the small number of patients and the short follow-up time can be considered as limitations of our study. A larger prospective, randomized study with, long-term follow-up is needed to more accurately assess the effectiveness of this method. The inside of joint cannot be evaluated in detail using this method. For this reason, the method should not be employed in those with chronic infection or in patients who will undergo synovectomy. In addition, an open intervention would be more appropriate under regional or general anesthesia in the presence of concomitant metaphyseal osteomyelitis.

In conclusion, the anesthetic doses described here are appropriate for local anesthesia and are safe in terms of complications. Mini-open surgery under local anesthesia appears to be a good option when the patient has high risk for general anesthesia. We conclude that this method can safely and effectively be performed under local anesthesia without the need for arthroscopy equipment and fasting period.

Scientiﬁc Responsibility Statement

Animal and human rights statement

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

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Mehmet Fethi Ceylan, Savas Guner, Ugur Turktas, Levent Ediz, Ugur Goktas, Ali Dogan. Mini open surgical treatment of knee septic arthritis with local anesthesia: a prospective prelimina. J Clin Anal Med. 2018;9(1):77-81

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Oocyte pick up day mucus removal: Does it have a positive effect on pregnancy rates?

Semih Kaleli 1, Tayfur Çift 2, Sinan Güngör 3, Hülya Şenol 4, Birsen Yıldız 5, Ertan Kervancıoğlu 1

1 Department of Gynecology and Obstetrics Division of Artificial Reproductive Technics Units, Cerrahpasa Medical School, İstanbul, 2 Department of Gynecology and Obstetrics, Bursa Yüksek İhtisasTraining and Research Hospital, Bursa, 3 Department of Gynecology and Obstetrics, Süleymaniye Training and Research Hospital, İstanbul, 4 Department of Gynecology and Obstetrics, Division of Artificial Reproductive Technics Units, Biologist. Cerrahpasa Medical School, İstanbul, 5 Department of Gynecology and Obstetrics, Nurse, Cerrahpasa Medical School, Division of Artificial Reproductive Technics Units, İstanbul, Turkey

DOI: 10.4328/JCAM.5460 Received: 30.20.2017 Accepted: 01.12.2017 Published Online: 01.12.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 73-6

Corresponding Author: Tayfur ÇİFT, Department of Gynecology and Obstetrics, Bursa Yüksek İhtisas Training and Research Hospital, 16140, Bursa, Turkey. GSM: +905325521928 E-Mail: tayfur_cift@yahoo.com

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Aim: Mucus removal that would be done on the day of embryo transfer could be done on Oocyte pick up(OPU) day, and this practice might be related with better pregnancy rates since it is unlikely to cause uterine contractions during the embryo transfer. We compared the effects of mucus removal done on OPU day, transfer day or no removal at all on success rates of the treatment in three groups. Material and Method: We designed a prospective match control study. There were 131 cycles in which mucus removal was done on either OPU day or embryo transfer day (64 and 67 cycles respectively) and in 411 cycles mucus removal was not done, and these patients constituted the control group. Results: After mucus removal on OPU day, mucus removal on embryo transfer day and no mucus removal done at all, pregnancy rates were calculated as 40,6%, 29,9%, and 23,1% respectively and the difference among the groups was statistically significant (p=0,009). Discussion: Mucus removal on OPU day or on embryo transfer day improves pregnancy rates. It can be included in the routine practice, since it may potentially minimize cervical trauma and uterine contractions and thus improve success in IVF/ICSI treatments.

Keywords: Cervical Mucus; Embryo Transfer; Pregnancy Rates; Transfer Timing; Oocyte Pick Up

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Introduction

Currently, Assisted Reproductive Technologies help countless couples become parents. These techniques achieve success in 25 to 40% of all procedures [1-3]. As the eventual goal is the realization of a healthy baby, researchers continuously search for reasons of failure and the ways to overcome these.

The success of embryo transfer which is the final step in IVF/ICSI treatments depends on additional factors other than endometrial receptivity and the quality of embryos. Ultrasound guidance, myometrial contractions, type of transfer catheter or the mode of loading, dummy transfer, the site that the embryos were placed, presence of cervical mucus and /or blood, a blood-stained catheter after transfer or an embryo stuck in the catheter are some such factors [4-6].

Sperms need to go through vagina and cervix and reach upper genital system for fertilization and to achieve this they have to penetrate into the cervical mucus (CM) which is a hydrolyzed gel containing various forms of mucin. CM is maximally hydrated during ovulation. Its pores are smaller than the heads of the sperms and sperms have to pass through these pores to reach the upper genitals. Higher rates of in vivo or in vitro pregnancies are related to the sperms which managed to penetrate through this barrier [7,8].

Occasionally there is mucus smeared on the cervix impeding the embryo transfer. Transferring the embryos may be complicated when the cervix is covered with mucus. It is considered that as the inner catheter used for embryo transfer is made of soft material, the cervical catheter might obliterate the catheter, impede the transfer of embryo(s) to the desired location or cause damage to the embryo(s) [2,3,9].

Conversely, removing the mucus which acts as a natural lubricant might complicate transfer[10]. Additionally, poking the cervix or the endocervix during the mucus removal might trigger uterine contractions and lead to decreased pregnancy rates[4].

We anticipated that the mucus removal that would be done on the day of embryo transfer could be done on OPU day and this practice might be related with better pregnancy rates since it is unlikely to cause uterine contractions during the embryo transfer. In this study, we compared the effects of mucus removal done on OPU day, done on transfer day or no removal at all on success rates of the treatment in three groups. We also performed a thorough review of the literature and discussed the influences on routine practices.

Material and Method

Study Design:

In order to evaluate the effect of timing of mucus removal on pregnancy rates, we designed a prospective match control study in which the records of 447 IVF/ICSI patients who had a total of 542 procedures were compared. There were 131 cycles in which mucus removal was done on either OPU day or embryo transfer day (64 and 67 cycles respectively) and in 411 cycles mucus removal was not done, and these patients constituted the control group. The study was conducted in a university setting, and the primary outcome was set as pregnancy rate.

Patients:

This study was a prospective match control study conducted on the records of patients who were treated in Istanbul University, Cerrahpasa School of Medicine, Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility. Mucus removal was done either before the OPU or the embryo transfer, and these patients were compared with those who had OPU and embryo transfer without any mucus removal at all. Institutional Review Board approved the study. There were 447 patients in total, and these patients underwent 542 IVF/ICSI cycles. In mucus removal group which consisted of patients who had mucus removal either during OPU or embryo transfer, in 64 cycles, mucus removal was done before OPU, and in 67 cycles it was done before embryo transfer. In 411 cycles no mucus removal was done at all. Cases in which embryo transfer was canceled were excluded from the study.

Stimulation protocols:

In agonist protocols, leuprolide acetate (Lucrin, Abott) was used as Gonadotropin-Releasing Hormone (GnRH) agonist and in antagonist protocol GnRH antagonist cetrorelix (Cetrotide, Serono) was used. Urinary or recombinant gonadotropin doses were arranged according to follicle dimensions measured by ultrasonography and serum E2 levels.Ovulation trigger of the oocytes was done by an injection of 10000IU urinary hCG(Pregynl, Organon) or 250mcg recombinant hCG (Ovitrelle, Serono). Oocyte retrieval was performed 36 hours after the hCG injection under general anesthesia and ultrasound guidance.

Embryo selection and transfer:

All of the embryos were obtained by applying ICSI method on the oocytes. Patients under 35 received a single embryo while patients over 35 and any patient with at least 2 prior failed IVF/ICSI trials had 2 embryos transferred. All embryo transfer procedures were performed exclusively by certified staff physicians in the unit. All oocyte retrievals and embryo transfers were done in the same operating room. (Patient admission and follicle measurements were done in a separate room). Patients were put in a lithotomy position on a gynecologic examination chair. Cervix was made visible by using a metal bivalve speculum, and external cervical os was cleaned with a saline solution, and cervical mucus was removed by using a cotton swab and a polyvinyl propylene catheter mounted on a 10 cc syringe to create negative pressure and aspirate the mucus. All of the embryo transfers were done under ultrasound guidance. After the transfer is complete, each catheter tip was checked for blood stain or residual mucus. They were inspected with a microscope to rule out any retained embryos in the catheter, as well. Vaginal progesterone (Crinone gel % 8, Serono) was given to all patients after each transfer for luteal phase support. Serum bHCG level was measured for detecting the pregnancy 12 days after the transfer.

Statistical Analysis:

Statistical analysis was performed using the SPSS (Statistical Program for Social Sciences, Chicago, IL, USA) program. Data were characterized by means, standard deviations, and percentages. A p-value <0.05 was considered as statistically significant.

Limitations of the study:

The study design was a prospective match control study, thus any randomization was irrelevant. Patients in the groups were treated with long agonist protocol and antagonist protocol. Lack of other types of treatment protocols is a limitation of the study. In our IVF unit, patient follow-up is done by a team of specialists instead of a single physician. Thus, follicle measurements, mucus removal procedures, and embryo transfers were not performed by the same person. The patients were enrolled in the study and divided into groups should the specialist taking part in their treatment procedures had similar success rates of embryo transfer.

Results

A total of 447 patients and 542 IVF/ICSI cycles undergone by these patients were included in the study. OPU day cervical mucus removal was done in 64 patients, mucus was removed on the embryo transfer day in 67 cycles, and no removal at all was attempted in 411 cycles. Demographics and biochemical test results of the patients in the groups are given in Table 1.Three groups were similar in mean age, BMI, gravidity, parity and the duration of infertility (p values: 0.20; 0.42; 0.18 and 0.23 respectively). Mean values of total duration of ovarian hyperstimulation in each group were 9,07 ± 1,9; 8,9 ± 1,9; 9,5 ± 1,9 days respectively and the difference was insignificant among the groups (p=0,41). In our study, after mucus removal on OPU day(Table 2), mucus removal on embryo transfer day and no mucus removal done at all, pregnancy rates were calculated as 40,6%, 29,9%, and 23,1% respectively and the difference among the groups was statistically significant(p=0,009).

Discussion

It is anticipated that removing cervical mucus before the embryo transfer will facilitate the translocation of the embryo into the uterine cavity and thus improve the rates of clinical pregnancy rates and therefore live birth rates.

In approximately 30% of all patients undergoing embryo transfer experience powerful uterine contractions which lead to unfavorable results of IVF treatments. Inducing uterine contractions (>5 per minute) during embryo transfer may result in impaired embryo implantation[11]. In addition, the presence of blood and/or mucus, bacterial contamination, avoiding trauma and uterine contractions are all factors related to optimal rates of implantation and pregnancy[12].

Removal of cervical mucus during embryo transfer improves rates of implantation and pregnancy independently from embryo implantation. However, cervical mucus removal may trigger undesired uterine contractions, as well[10].

A literature review revealed that in a study, frequency and directions of uterine contractions were compared in fresh transfers after IVF treatment. In the prospective cohort study, 286 women were investigated. In embryo transfers after IVF, frequency and directions of uterine contractions were evaluated 5 minutes before, 5 minutes and 60 minutes after the embryo transfer procedure. In the group with increased frequency of contractions at 5 minutes after the procedure, pregnancy rates were lower, and the difference was statistically significant (p=0,006). The authors concluded that frequency of uterine contractions 5 minutes after the embryo transfer was significant in determining the results of IVF and could be useful in selecting the patients who would benefit from muscle relaxants to improve the IVF results[13].

A meta-analysis focussed on the effectiveness of oxytocin antagonist infusion on embryo transfer day. Out of 123 studies taken into consideration, 3 randomized controlled trials were eligible for the meta-analysis. Atosiban (Tractocile, Ferring Arzneimittel, Kiel, Germany) is a well-known antagonist of oxytocin/vasopressin V1a receptor, and it is usually used for preventing preterm delivery. In the study, researchers investigated the effect of atosiban on IVF cycles, as uterine contractions are associated with unfavorable IVF results. Meta-analysis revealed that administration of oxytocin antagonist on embryo transfer day increased implantation rates but clinical pregnancy rates and abortion rates remained the same. Furthermore, they suggested that prospective randomized trials with higher sample sizes should be done to confirm their conclusions[11].Authors investigated the effect of blood and mucus on the catheter tip after the embryo transfers on the rates of implantation and pregnancy. A total of 8311 embryo transfers were assessed retrospectively. Presence of blood stain on the tip of the catheter was associated with a decrease in the rates of implantation, clinical pregnancy, and live birth. On the other hand, a mucus remnant on the tip was considered a simple contamination which has practically no effect on pregnancy rates. Freely floating blood clot fragments in the endometrial cavity which result from cervical trauma were anticipated to trigger uterine contractions and prevent the embryo from implanting on the desired site and such a phenomenon would lead to significantly decreased rates of implantation and clinical pregnancy[6].

In a study comprising 317 patients and 428 cycles done, mucus removal done before the embryo transfer was compared with a control group which did not receive any intervention. Mucus removal immediately preceding the embryo transfer did not increase the live birth rates significantly. However, the authors suggested the practice of mucus removal even if the overall contribution to success was trivial since it is a simple and inexpensive procedure[11]. Similarly, we found that performing mucus removal and doing this procedure on a day other than the embryo transfer day could increase pregnancy rates.

Furthermore, in a systematic review and meta-analysis covering 8 randomized controlled studies containing 1715 IVF/ICSI patients, the effect of cervical mucus removal before the embryo transfer on implantation and pregnancy rates was investigated. Studies included in the review were low to intermediate quality, and the researchers concluded that mucus removal done before the embryo transfer in IVF/ICSI patients had a very small benefit. The results also suggested that implantation, clinical pregnancy, and live birth rates were similar[4].

In another study, the authors stated that mucus remnants on the tip of embryo transfer catheter was associated with lower implantation and pregnancy rates[1,10,12]. Although contradicting views and publications coexist in the literature, we maintain the view that cervical mucus removal may improve the clinical pregnancy rates[1,10].

In our study, OPU day mucus removal group was compared with no removal group, and pregnancy rate improved significantly in the first group (p=0,003). Similarly, the embryo transfer day mucus removal group had better pregnancy rates compared with no removal group, but this difference did not reach statistical significance (p=0,232).

As a conclusion, mucus removal on OPU day or on embryo transfer day improves pregnancy rates. Although the difference in the pregnancy rates between OPU day and embryo transfer day mucus removal is not statistically significant, it can be included in the routine practice, since it may potentially minimize cervical trauma and uterine contractions and thus improve success in IVF/ICSI treatments.

Scientiﬁc Responsibility Statement

Animal and human rights statement

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

References

1. Tıras B, Cenksoy PO. Practice of embryo transfer: recommendations during and after. Semin Reprod Med. 2014;32(4):291-6.1. Tıras B, Cenksoy PO. Practice of embryo transfer: recommendations during and after. Semin Reprod Med. 2014 Jul;32(4):291-6.

2. Akhtar MA, Netherton R, Majumder K, Edi-Osagie E, Sajjad Y. Methods employed to overcome difficult embryo transfer during assisted reproduction treatment. Arch Gynecol Obstet. 2015;292(2):255-62.

3. Caanen MR, van der Houwen LE, Schats R, Vergouw CG, de Leeuw B, Lambers MJ, et al. Embryo Transfer with Controlled Injection Speed to Increase Pregnancy Rates: A Randomized Controlled Trial. Gynecol Obstet Invest. 2016;81(5):394-404.

4. Craciunas L, Tsampras N, Fitzgerald C. Cervical mucus removal before embryo transfer in women undergoing in vitro fertilization/intracytoplasmic sperm injection: a systematic review and meta-analysis of randomized controlled trials. Fertil Steril. 2014;101(5):1302-7.

5. Omidi M, Halvaei I, Mangoli E, Khalili MA, Razi MH. The effect of embryo catheter loading technique on the live birth rate. Clin Exp Reprod Med. 2015;42(4):175-80.

6. Tiras B, Korucuoglu U, Polat M, Saltik A, Zeyneloglu HB, Yarali H. Effect of blood and mucus on the success rates of embryo transfers. Eur J Obstet Gynecol Reprod Biol. 2012;165(2):239-42.

7. Morales P, Roco M, Vigil P. Human cervical mucus: relationship between biochemical characteristics and ability to allow migration of spermatozoa. Hum Reprod. 1993;8(1):78-83.

8. Tollner TL, Yudin AI, Treece CA, Overstreet JW, Cherr GN. Macaque sperm coating protein DEFB126 facilitates sperm penetration of cervical mucus. Hum Reprod. 2008;23(11):2523-34.

9. Teixeira DM, Dassunção LA, Vieira CV, Barbosa MA, Coelho Neto MA, Nastri CO, et al. Ultrasound guidance during embryo transfer: a systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol. 2015;45(2):139-48.

10. Eskandar MA, Abou-Setta AM, El-Amin M, Almushait MA, Sobande AA. Removal of cervical mucus prior to embryo transfer improves pregnancy rates in women undergoing assisted reproduction. Reprod Biomed Online. 2007;14(3):308-13.

11. Kim SK, Han EJ, Kim SM, Lee JR, Jee BC, Suh CS, et al. Efficacy of oxytocin antagonist infusion in improving in vitro fertilization outcomes on the day of embryo transfer: A meta-analysis. Clin Exp Reprod Med. 2016;43(4):233-9.

12. Schoolcraft WB, Surrey ES, Gardner DK. Embryo transfer: techniques and variables affecting success. Fertil Steril. 2001 Nov;76(5):863-70.

13. Chung CH, Wong AW, Chan CP, Saravelos SH, Kong GW, Cheung LP, et al. The changing pattern of uterine contractions before and after fresh embryo transfer and its relation to clinical outcome. Reprod Biomed Online. 2017;34(3):240-7.

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Semih Kaleli, Tayfur Çift, Sinan Gungör, Hülya Şenol, Birsen Yıldız, Ertan Kervancıoğlu. Oocyte Pick Up Day Mucus Removal: Does it have a positive effect on pregnancy rates?. J Clin Anal Med. 2018;9(1):73-76

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Factors affecting mortality in rectus sheath hematoma: A retrospective study

Nezih Akkapulu, İlker Murat Arer, Abdirahman Sakulen Hargura, Murat Kuş, Hakan Yabanoğlu, Hüseyin Özgür Aytaç

Department of General Surgery, Baskent University Adana Research, and Teaching Hospital, Adana, Turkey

DOI: 10.4328/JCAM.5453 Received: 26.10.2017 Accepted: 13.11.2017 Published Online: 13.11.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 69-72

Corresponding Author: Nezih Akkapulu, Baskent University, Adana Hospital 01120 Yuregir, Adana, Turkey.T.: + 90 3223272727 F.: +90 3223271274 E-Mail: akkapulu@gmail.com

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Aim: Rectus sheath hematoma is a rare clinical condition. Because it could mimic various intra-abdominal pathologies suspicious approach and attention is needed for proper diagnosis and management of rectus sheath hematoma. The aim of this study is a review of factors affecting mortality in patients with rectus sheath hematoma besides clinical features, diagnosis modalities, treatment periods and results of patients with rectus sheath hematoma. Material and Method: Twenty-three patients with rectus sheath hematoma from January 2012 to March 2017 in a tertiary care center were included in the study. Patients’ files were reviewed retrospectively. Reviewed variables were demographic and clinical features, symptom and findings, co-morbidities, medications, laboratory findings, diagnostic modalities, APACHE II scores, treatment approaches, transfused blood products and length of hospital stay. Results: Fifteen (65.2%) of the patients were women, and 8 (34.8%) of the patients were men. The mean age was 61.9 ±13.5. Seventeen (74%) of the patients had abdominal pain. Twenty (87%) of the patients had anticoagulant and antiplatelet therapy.The mean hematoma diameter was 6.3± 3.6 cm. The mean APACHE II score for the patients was 13.1±7.3. One patient had undergone surgery. There was mortality in 3 (13%) of the patients. The median length of stay in hospital was 5 (5) days. Discus-sion: The diagnosis of rectus sheath hematoma should be kept in mind while assessing old female patients and patients on anticoagulants with a complaint of abdominal pain. In our study, we identify risk factors such as higher APACHE –II scores, the presence of a transient ischemic attack, need for transfusion of more units of packed erythrocytes and more extended hospital stay as factors associated with mortality.

Keywords: Rectus Abdominis; Hematoma; Mortality

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Introduction

Rectus sheath hematoma (RSH) is a rare clinical condition that is caused by the occurrence of hematoma in rectus muscle or within muscle sheath following the injury to the branches of the superior epigastric artery. RSH could be observed after blunt or penetrating abdominal trauma, vigorous exercise, recent abdominal surgery, at trocar sites after laparoscopic surgery, abdominal wall injections, paracentesis or it could occur spontaneously in the presence of predisposing factors such as anticoagulation therapy and intractable coughing [1]. RSH could also mimic appendicitis or sepsis [2].

There are well-defined predisposing factors, clinical features, diagnostic classification by abdominal computerized tomography (CT) and treatment options for RSH in the literature [3]. However; there is lacking consensus about RSH related mortality and risk factors affecting mortality in patients with RSH.

We aimed to investigate risk factors that influence mortality in patients with RSH primarily. The secondary purpose of this study is an overview of clinical characteristics, diagnosis modalities, treatment options and results of the patients with RSH.

Material and Method

Twenty-three patients with rectus sheath hematoma from January 2012 to March 2017 in a tertiary care center were included in the study. Patients’ files were reviewed retrospectively. Exclusion criterion was pediatric age group (0-16 years old) patients. We described 54 variables such as age, gender, symptoms, and clinical findings of the patient, co-morbidities, medications, laboratory findings, diagnostic modality, CT classification, hematoma side, the diameter of hematoma, Acute Physiology and Chronic Health Evaluation (APACHE)- II score at the time of diagnosis, treatment options, transfused blood products, length of hospital stay (LOS) and presence of mortality after reviewing the files.

We composed two independent groups due to the presence or absence of mortality to assess possible risk factors. IBM SPSS statistic software version 24.0 (IBM Corp., Armonk, NY, USA) was used for statistical analyses. Shapiro-Wilk test was applied to determine the distribution of normality. Normally distributed quantitative variables were expressed as the mean ± standard deviation (SD), quantitative variables not normally distributed were expressed as median with interquartile range and categorical variables as frequency and percentage. Student-t-test was applied to normally distributed quantitative variables of independent groups. Mann-Whitney U test was used for quantitative variables without normally distributed data of separate groups. Chi-square test was applied to categorical variables. Logistic regression model was carried out for multivariate analyses. A value of p< 0.05 was considered as statistically significant.

This study was approved by Baskent University Institutional Review Board (Project no: KA17/132)

Results

A total of the 23 patients, 65.2% were women, and 34.8% were men. The mean age was 61.9± 13.5 years (range 31 – 87 years). 87% of the patients had at least one co-morbid disease. 87% of the patients were receiving anticoagulant or antiplatelet therapy, and 34.8% of patients were receiving both anticoagulant and antiplatelet therapy. RSH developed at trocar site after laparoscopy in three of the patients (13%), due to paracentesis in two of the patients (8.7%) and after blunt abdominal trauma in one of the patients (4.3%). One patient was pregnant. Conservative treatment was chosen for 20 (87%) of the patients; transcatheter embolization was performed for two (8.7%) of the patients, and one (4.3%) patient was operated on. Patients’ clinical features are shown in Table 1 and Table 2.

Mortality rate was 13%. The mean age was 53.3±7.5 (range 48- 62), the mean Co-morbid disease numbers were 3.3± 1.1 (range: 2- 4), the mean APACHE-II score was 27 ±4.5 (range: 23- 32), the median transfused packed erythrocytes units were 9(0) (Range: 6- 16 units), the median LOS days were 11(0) (range: 8- 21 days) in mortality group. Conservative management was utilized for two of the patients and surgery was selected for one patient in the group.

We detected a significant difference between mortality and APACHE –II scores, the presence of a transient ischemic attack, LOS, and transfused units of packed erythrocytes.

Discussion

We investigated factors affecting mortality and overviewed clinical features in the patients with RSH in this retrospective study. We found that mortality rate is 13% and this ratio is compatible with the literature. The mortality rate of the largest case series of 126 patients from Mayo Clinic was 1.6% [4]. The mortality rate in patients with RSH ranges from 0% to 14.7 % in various studies [5]. Villa et al. [6]reported that mortality rate was 17% among the patients who had to undergo surgery because of the hemodynamic instability of the patients. Carkman et al. [7]stated that the mortality rate could reach 20% in elderly and patients receiving anticoagulant therapy presenting with RSH. In this univariate analysis, we found that higher APACHE- II scores, the presence of TIA, need for more erythrocytes transfusion, and longer LOS are associated with the occurrence of mortality. We could not reveal significant differences between mortality and any variable in the multivariant analysis. While the median units of transfused erythrocytes were 3.5 units in the previous study [4], our patients needed more erythrocytes transfusion (the median is nine units). The length of stay in hospital ranges from 4 to 10 days in previous studies [8]. In our study, the median LOS was 11 days in mortality group and 4.5 days in surviving group. We think that patients had to limit physiologic conditions beforehand resulting in more transfusions and longer stay in hospital in mortality group.

Higara et al. [9] reported that mortality rate was 0.28% in ischemic stroke patients with RSH and they indicated that patients were receiving both antiplatelet and anticoagulant therapy. In our study, mortality occurred in two of the three TIA patients. While one of the mortality cases was receiving both antiplatelet and anticoagulant therapy, the other patient was receiving only anticoagulant therapy. However, we could not derive a relation between mortality and anticoagulant therapy.

We noted that women to men ratio was 1.8:1 and is compatible with previous studies, nevertheless, we could not reveal any additional risk factor for female patients with RSH.

The range of age was 46 – 69 years in previous research [10] and the mean age was 61.9 ±13.5 (range: 31-87) in our study. Patients developing RSH are mostly elderly, and this could be explained with these elderly patients being more liable to be on anticoagulant therapy. We also found lower INR levels than the previous study [4].

CT scan was performed for all patients except the pregnant one. CT scan is widely accepted as first-line diagnostic modality because of its superiority to ultrasound. Because it reveals hematoma size, location, and relation with peritoneum, CT scan could aid in shortening time for surgical decision-making period.

Most of the RSH patients were treated conservatively, that includes nil per os, intravascular hydration, bed rest and administering analgesics. Transcatheter embolization was performed for two patients, and surgery for hematoma drainage with bleeding control was conducted for one patient. Surgical decision-making depends on the hemodynamic instability of the patient with RSH [6]. Scoring systems such as APACHE- II could be used to decide which patient to take to surgery before developing hemodynamic instability.

The study has some limitations: its retrospective in nature, a tertiary center analysis and a small number of patients that could have resulted in findings of higher mortality rate.

In conclusion, there are various predisposing factors for RSH. RSH should be kept in mind while evaluating geriatric female patients and patients on anticoagulant with a complaint of abdominal pain. Furthermore, we note that risk factors such as higher APACHE –II scores, the presence of TIA, transfusion of more units of packed erythrocytes and longer hospital stays are associated with an increase in mortality.

Scientiﬁc Responsibility Statement

Animal and human rights statement

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

References

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2. Kasotakis G. Retroperitoneal and rectus sheath hematomas. Surg Clin North Am. 2014;94(1):71-6.

3. Oh JH, Kim TH, Cha SJ, Kim SH. Rectus sheath hematoma caused by non-contact strenuous exercise mimicking acute appendicitis. J Emerg Med. 2010;39(3):e117-9.

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Nezih Akkapulu, İlker Murat Arer, Abdirahman Sakulen Hargura, Murat Kuş, Hakan Yabanoğlu, Hüseyin Özgür Aytaç. Factors affecting mortality in rectus sheath hematoma: A retrospective study. J Clin Anal Med. 2018;9(1):69-72

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The relationship between restless leg syndrome and 25-hydroxy D vitamin in hemodialysis patients

Can Hüzmeli 1, Ferhan Candan 1, Meryem Timucin 1, Demet Alaygut 2, Lale Akkaya 3, Ayşe Şeker 1, Mansur Kayataş 1

1 Department of Nephrology, 2 Department of Pediatric Nephrology, 3 Department Pertitoneal Dialysis Nurse, Cumhuriyet University Faculty of Medicine, Sivas, Turkey

DOI: 10.4328/JCAM.5452 Received: 26.10.2017 Accepted:12.11.2017 Published Online: 12.11.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 65-8

Corresponding Author: Can Hüzmeli, Department of Nephrology, Cumhuriyet University Faculty of Medicine, 58140 Sivas, Turkey.T.: +90 3462581358 GSM: +905067159443 F.: +90 3462580024 E-Mail: chuzmeli@hotmail.com

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Aim: The purpose is to evaluate the relationship between Restless legs syndrome (RLS) and 25-Hydroxy D [25 (OH) D] vitamin level among hemodialysis patients. Material and Method: Hemodialysis patients, in Cumhuriyet University Faculty of Medicine Department of Nephrology were included in this study. Patients were asked about the diagnosis criteria of the International RLS study group and their laboratory examinations along with 25 (OH) D vitamin levels were assessed. Results: Seventy-five patients, 40 of whom were female, were included in the study. The average age of patients was 57.8 (19-84). Average 25 (OH) vitamin D levels of 75 patients in total were found to be 12.6 ±6.27 (3-30). Five patients had 25 (OH) D vitamin insufficiency and 70 had 25 (OH) D vitamin deficiency. Thirty-three patients were diagnosed with RLS and their average vitamin D levels were 10.76 ±4.56; the D levels of 42 patients not diagnosed with RLS were found to be 14.18±7.02. A significant relationship was determined between the patients diagnosed with RLS and their vitamin D levels (p=0.018). Discussion: A significant relationship was determined between RLS and 25 (OH) vitamin D level among hemodialysis patients. The fact that frequency of RLS was higher among hemodialysis patients compared to the general population may be related to low levels of 25 (OH) D vitamin.

Keywords: Hemodialysis; 25 (OH) D Vitamin; Rest-Less Leg Syndrome

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Introduction

Restless legs syndrome (RLS) is a condition characterized by an uncomfortable sensation, pain and cramp in legs, involuntary leg movements and related sleep disorders which occur especially during sleep at night [1]. Having increasing and more apparent symptoms during resting at night is typical. RLS is diagnosed through the urge to move extremities along with paresthesia or dysesthesia sensations, increasing symptoms during resting and decreasing symptoms during moving, inability to stand still (walking, shaking, contraction, and rubbing) and aggravating symptoms at night. The frequency of RLS is around 5-15% in the general population [2]. Recently, RLS is commonly seen due to end-stage renal failure. Its prevalence has a wide distribution range of 6.6% and 70% among dialysis patients, and it is significantly higher than the rates seen in the general population [1,3-4].

Vitamin D metabolism disorders are commonly seen in chronic kidney diseases (CKD). Vitamin D synthesis is related to the failure of turning 25 (OH) vitamin D into 1.25 (OH) D vitamin in renal dysfunction. Vitamin D deficiency is commonly seen in CKD. In a study conducted by Bansal et al., 45 hemodialysis patients were included in the study and 88.9% of them (n= 40) were diagnosed with vitamin D deficiency [25 (OH) vitamin D < 20 ng/ml] and 29 patients were diagnosed with severe vitamin D deficiency [25(OH) vitamin D < 10 ng/ml]. Two patients were found to have normal levels whereas 3 patients have vitamin D insufficiency (vitamin D between 20-30 ng/mL). It was reported that 23 of these patients (51%) received vitamin D treatment and their average 25 (OH) vitamin D level was 10.14+-8.7 ng/ml [5].

In conducted studies, CKD is indicated as the secondary reason of RLS. However, its etiology is not exactly known. RLS is more commonly encountered in CKD compared to the general population. The purpose of this study was to reveal the relationship between vitamin D level and RLS on the basis of the fact that vitamin D deficiency is frequent in CKD.

Materials and Method

Seventy-five hemodialysis patients who applied to our outpatient clinic and received hemodialysis treatment in our center between March 2012 and May 2012 were included in the study. Chronic renal failure patients who were older than 18 years of age and were receiving hemodialysis treatment at least for three months were included in the study. Patients diagnosed with a peripheral arterial disease, hemiplegia and mentally retarded patients were excluded from the study. Blood samples of patients were analyzed for their 25 (OH) vitamin D, serum iron, iron binding capacity, ferritin, calcium, phosphorus, parathyroid hormone, and complete blood counts before hemodialysis.

Diagnosis criteria specified by the International RLS study group and shown in Table 1 were used for diagnosing of RLS. Diagnosis of RLS has required all diagnosis criteria to be positive.

Statistical analysis

The data obtained from our study were evaluated by using SPSS 14.0 program. Two independent t tests were used when parametric test assumptions were performed, and Mann Whitney U test and Chi-square test were used when non-parametric test assumptions were performed, and level of significance was accepted as 0.05.

Results

A total of 75 patients were included in the study, the average age of patients was 57.8 (19-84), 40 patients were female whereas 35 were male. The average vitamin D levels of 75 patients in total were 12.6 ±6.27 (3-30) ng/ml. Seventy patients (93.3%) had 25 (OH) D vitamin level deficiency (≤ 20 ng/ml), and 5 patients (6.7%) were diagnosed with 25 (OH) D vitamin insufficiency ( 20-30 ng/ml). Twenty-three of these patients (30.6%) had vitamin D levels of < 10 ng/ml. Tables 2 and 3 illustrate demographic and laboratory data of patients.

The average age of individuals with RLS was 59.6±12.9 years, and 24 of them were female. The average age of individuals without RLS was 56.65±15.77 years, and 16 of them were female. No difference was found between groups in terms of age. However, a significant difference was found between genders in terms of RLS. (X²p=0.005). RLS was detected more frequently in female patients. When vitamin D levels (10.76 ±4.56 ng/ml) of 33 individuals with RLS and vitamin D levels (14.18±7.02 ng/ml) of 42 individuals without RLS were compared, a significant relation was determined between vitamin D levels and individuals with RLS (p=0.018).

Twenty-six of individuals with RLS (78.8%) and 32 of individuals without RLS (76.2%) had anemia. When RLS was examined regarding anemia, no statistical difference was found between the two groups. None of the individuals with RLS had low ferritin levels. Two individuals without RLS had low ferritin levels. When RLS was examined regarding ferritin, iron, serum iron binding capacity, saturation of transfer, calcium, phosphorus and parathormone, Kt/V no significant difference was determined.

Discussion

In our study there was no difference between the two groups in the age distribution. The average age of patients was found to be 57,8 (19-84). Average vitamin D levels of 75 patients in total were 12.6 ±6.27 (3-30). Twenty-three of these patients (30.6%) had very low vitamin D levels [25 (OH) vitamin D < 10 ng/ml]. Ninety three point three percent (93.3%) of patients (70) had 25 (OH) vitamin D level deficiency and 6.7% of patients had (5) 25 (OH) vitamin D insufficiency. None of the patients included in the study had a sufficient level of vitamin D. RLS was defined by Ekbom for the first time in 1994. It is characterized by a sensation of discomfort, pain, and cramps in legs and involuntary leg movements which occur especially during sleep at night [1]. RLS is the apparent sensation of discomfort in lower extremities which increase generally at night when complaints are on the rise, with an urge to move legs and decrease when legs are moved. It may be associated with idiopathic, hereditary (primary RLS) or other clinical conditions, and may have secondary reasons such as iron deficiency, end-stage renal failure, pregnancy, rheumatic diseases, and diabetes mellitus. Also, it may also be encountered in neurological conditions (Parkinson, spinal cord lesions, multiple sclerosis, polyneuropathy) [6].

RLS was defined by Callghan for the first time in 20 chronic renal failure patients [7]. In a study conducted by Rogers et al., in 1991, the frequency of RLS was 40% in 55 patients (34 hemodialyses and 21 peritoneal dialyzes) [8]. In a study conducted by Çölbay et al., in Turkey, the frequency of RLS in hemodialysis patients was 43.3% [9].

The fact that RLS symptoms responded to dopamine agonists and levodopa has been considered as proof that dopaminergic dysfunction plays a role in RLS pathophysiology [10]. Additionally, metoclopramide which is a dopamine antagonist showed that pimozide increased RLS symptoms [11-12]. It is remarkable that RLS symptoms increase at night when dopamine levels are the lowest and decrease in morning hours when dopamine levels are higher, in compliance with dopamine circadian rhythm. Dopaminergic agents are used for primary RLS treatment; however etiology-focused treatments are preferred for secondary RLS (pregnancy, end stage renal failure and anemia) [13].

Parkinson’s disease is characterized by the loss of dopaminergic cells gradually in the nigrostriatal pathway. Early findings of Parkinson’s disease were observed in case of bradykinesia, walking disorders, rigidity, and the loss of tremor strial dopamine at a rate of 80-90% and nigral dopaminergic neurons at a rate of 50% [14-17]. In a cohort study conducted by Knekt et al., in Finland, they examined the relationship between vitamin D levels and risk of Parkinson’s disease and as a result of 29-year follow-up of 3713 individuals above the age of 50, they found out that the individuals, who had low vitamin D levels, in the beginning, had higher risk of Parkinson’s disease [18]. In a study conducted by Evatt et al., with Parkinson’s and Alzheimer’s disease patients, they found out that the vitamin D deficiency prevalence of Parkinson’s disease patients was higher compared to Alzheimer’s and control groups. Researchers reported that the vitamin D insufficiency in Parkinson’s disease patients was 55% whereas vitamin D deficiency was 23% [19].

In a recently conducted study, the presence of vitamin D receptor was proved in the dopaminergic neurons in human and rat brains. Due to the nuclear location of vitamin D receptors, it is asserted that vitamin D could affect cell proliferation, differentiation and even life cycles in these neurons. These results support the relationship of abnormal dopaminergic transmission diseases such as schizophrenia and Parkinson’s disease with vitamin D [20].

It was reported in an in-vitro study that the increasing intense expression of vitamin D receptors in dopamine neurons in the brain, especially in the substantia nigra area increased the expression of tyrosine hydroxylase which is a rate-limiting enzyme in dopamine synthesis in adrenal medulla cells with the effect of 1.25 (OH) D2, D3 [21]. In addition, both vitamin D receptors and 1 alpha-hydroxylase enzyme are expressed in human brain, especially in substantia nigra neurons (probably dopaminergic) [22]. In animal experiments, it has been showed that 1.25 dihydroxy vitamin D which is the active metabolite of vitamin D could partly protect neurons against ischemic brain damage and the damages caused by 6- hydroxydopamine (a substance used to create Parkinson) [23-24].

In a study conducted by Balaban et al., 25 (OH) vitamin D levels of 36 patients with RLS (28 women and 8 men) were compared with 25 (OH) vitamin D levels of 38 healthy patients (27 female and 11 men). In this study, patients with secondary reason related RLS were not included in the study. While vitamin D level was 7.31 ng/mL in female patients with RLS, it was 12.31 mg/mL in healthy females. When two groups were compared, 25 (OH) vitamin D levels were significantly low in the group of patients with RLS (p=0.001) [25]. In this study, 25 (OH) vitamin D levels of 33 individuals with RLS were 10.76 ±4.56 whereas the 25 (OH) vitamin D levels of 42 individuals without RLS were 14.18±7.02. A significant relation was determined between the 25 (OH) vitamin D levels and RLS. (p=0.018).

Iron deficiency is related to RLS. It plays an important role in secondary reasons such as pregnancy and anemia. Iron is required as a cofactor for tyrosine hydroxylase, which is the rate-limiting enzyme for the formation of dopamine from levodopa. Therefore, dopamine synthesis may decrease in case of iron deficiency. A significant improvement is observed in some cases of RLS through iron treatment. In addition, iron concentration is also found to be low in substantia nigra in RLS patients [26-27]. In all groups where iron deficiency incidence is high, and in cases of pregnancy, end-stage renal failure and anemia, RLS incidence was 20-30% [27]. However, 75% of individuals with RLS are known to have decreasing iron stores [28]. In a study conducted on 79 patients with iron deficiency, 58% of patients had 25 (OH) vitamin D levels of < 30 ng/ml whereas 39% had levels of < 20 ng/ml [29]. In a study conducted by Balaban et al., ferritin levels between the groups with and without RLS were also found different, and ferritin levels were found lower in the women patients with RLS [25]. In a study conducted by Zbroch et al., dialysis (75 hemodialyses and 26 peritoneal dialyzes) patients were included in the study and dopamine levels of patients were low [30]. In this study, no significant relation was determined between anemia and RLS.

Consequently, vitamin D levels were significantly lower in hemodialysis patients with RLS. 25 (OH) vitamin D may be a factor for RLS etiology in hemodialysis patients. The fact that 25 (OH) vitamin D deficiency is frequent in CKD and dopamine level is low is an indicator that vitamin D deficiency may be responsible for dopamine deficiency in CKD.

Scientiﬁc Responsibility Statement

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Funding

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Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

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Can Hüzmeli, Ferhan Candan, Meryem Timucin, Demet Alaygut, Lale Akkaya, Ayşe Şeker, Mansur Kayataş. The relationship between restless leg syndrome and 25-hydroxy d vitamin in hemodialysis patients. J Clin Anal Med. 2018;9(1):65-68

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The use of fresh cadaveric cow brain as an experimental model for Sylvian fissure microdissection

Ahmet Gökyar 1, Enis Kuruoğlu 2, Cengiz Cokluk 2

1 Department of Neurosurgery, Amasya University, Faculty of Medicine, Amasya, 2 Department of Neurosurgery, Ondokuzmayis University, Faculty of Medicine, Samsun, Turkey

DOI: 10.4328/JCAM.5440 Received: 18.10.2017 Accepted: 01.12.2017 Published Online: 01.12.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 61-4

Corresponding Author: Ahmet Gökyar, Department of Neurosurgery, Amasya University, Faculty of Medicine, 05200 Amasya, Turkey. GSM: +905324656498 T.: +90 3582184000 F.: +90 3624576041 E-Mail: drgokyar@gmail.com

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Aim: The aim of this study was to evaluate the feasibility of using fresh cow brain as a training model for microsurgical dissection of Sylvian fissure. Micro-neurosurgical intervention to the brain includes many surgical activities performed by using metallic instruments to the vascular and/or parenchymal structure of the nervous system. For this purpose, an experimental micro-neurosurgical brain model using fresh cadaveric uncovered cow brain was used in the evalua-tion of the feasibility as a training model. Material and Method: Experimental micro-neurosurgical activities in this study were performed under the operating microscope. Bilateral Sylvian cisterns of the fresh cadaveric cow brain were used as an interested area for this experiment. The dissection and separation was continued reaching down to the floor of the cistern, and total dissection of the middle cerebral artery inside the cisternal space was performed. The suitability of a cow brain as a training model for Sylvian fissure microdissection was evaluated as three groups; bad, good, and perfect. Results: Ten uncovered fresh cadaveric cow brain were used in this experimental feasibility study. The suitability of the experiment for training model was evaluated as bad in (2) 20% of the fresh cadaveric cow brains. The suitability was found as good in (6) 60% of the procedures. In the remaining (2) 20% of the brain dissection, the suitability of the experiment was evaluated as perfect. Discussion: To sum up, safe surgical interventions require protecting of the brain tissue and neurovascular struc-tures. Thus, it’s extremely necessary to perform dissection and separation on neurovascular on training models before real practices on humans. Cow’s Sylvian cistern training model is feasible as shown in this experimental study. We believe that this training model will contribute to the practical micro-neurosurgery in various terms primarily, it helps to protect of neurovascular tissue. Additionally, it provides adequate performance for the microsurgical intervention around the Sylvian cistern.

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Introduction

Sharp and blunt dissection of the delicate neuroanatomical structures of the brain is commonly used in micro-neurosurgical practice. Some adjuvant-sophisticated systems may be used in the determination of the lesion location within the brain tissue. On the other hand, an adequate microsurgical technique including dissection, separation, and retraction of the sulcus and/or cisternae is extremely important in the prevention of bruised effect of metallic microsurgical instruments. The Microsurgical technique enables the neurosurgeon to dissect and expose the intracranial lesion such as aneurysms, vascular malformations and tumors in a natural pathway within the subarachnoidal cisterns and sulcus [7]. Specifically, stereoscopic magnification with deep zoom and sharp focus provides the neurosurgeon adequate view of the pathology [1]. Arachnoid dissection is the real key to successful aneurysm operations [7, 8]. Knowing the anatomy of subarachnoid cisternae is also important.

Specific micro-neurosurgical techniques such as proper use of the operative microscope, holding and grasping of the micro-neurosurgical instruments, a proper microsurgical technique of the opening of the arachnoid membranes, safe and delicate neurovascular dissection, and careful and proper micro-drilling of the cranial base bones should be learned before operating on a patient [1-7]. Theoretical knowledge, practical techniques, and microsurgical operative disciplines for the extreme protection of the delicate brain and related structures located within the cranium are mainly provided during the residency years of neurosurgical education [4, 5, 7].

Many neurosurgeons interested in microneurosurgery try to gain some additional and advanced progress in the improving their micro-neurosurgical ability including brain protection and delicate micro-neurosurgical techniques in laboratory training setting [2, 4, 5, 7]. Spending of time in experimental microsurgical laboratory to practice some microsurgical models such as dissection and suturing of the rat external carotid artery, dissection and evaluation of the abdominal vena cava of rats, suturing of the plastic glove materials by using microforceps under the operating microscope, drilling and dissection of the some cadaveric bone materials are essential improving and gaining of advanced micro-neurosurgical practical techniques [2, 4, 5, 7].

This experimental study aimed to evaluate the feasibility of cow Sylvian cistern dissection in the training of Sylvian cistern dissection. Experimental findings, difficulties, practical methods, and suggestions were discussed in line with the existing literature.

Material and Method

Experimental micro-neurosurgical activities in this study were performed under the operating microscope. Proximal and distal part of the lateral sulcus (Sylvian cistern) of the fresh cadaveric cow brain was used as an area of interest for this experiment. The uncovered cow brains were positioned laterally on the operating platform (Figure 1). The microsurgical dissection procedure was started from the distal part of the Sylvian cistern of the cow brains in the opening of the cisternal space (Figure 2). The superficial direction of the origin of the middle cerebral artery from the internal carotid artery was used in the identification of the location of the Sylvian cistern. The microsurgical dissection of the Sylvian cistern is shown in Figure 3. Microscissors was used for cutting off the delicate arachnoid membrane overlying the Sylvian cistern. Following the ten millimeters opening of the arachnoid membrane the dissection directed through the branch of the middle cerebral artery located inside the Sylvian cistern.

The dissection and separation was continued along the proximal part of the middle cerebral artery. The bifurcation of the middle cerebral artery could be seen in the middle of the Sylvian cistern (Figure 4). The main trunk, bifurcation, temporal and frontal branches of the middle cerebral artery was identified. The Sylvian fissure on the opposite side was dissected the same way. The suitability of the experimental process for micro-neurosurgical training model was evaluated within three groups as bad, good, and perfect.

The criteria for perfect, good and bad results were described as follows; In perfect result, the surgical specimens show no pial injury, cortical laceration, and separation following the surgical intervention. In good result, pial injury can be detected, but there is no cortical laceration. In bad result, pial and cortical injury, laceration and separation may be present.

Results

Ten uncovered fresh cadaveric cow brain were used in this experimental feasibility study. The specimens were positioned with resembling of real operations to the middle cerebral artery. Microscissors, micro bayonet and the tip of the metallic suction tube were used in the dissection of the cistern. The sharp edge of the microscissors was used to cut and open the arachnoid membrane. Our experiences revealed that the arachnoid membrane of the cow brain is more delicate and thin in comparison with the arachnoid membrane of the human brain. It is necessary to extremely pay attention during the cutting of the arachnoid membrane in the avoiding of the neural tissue injury. Cottonoids may be used to separate brain tissue to protect from the blunt corner of the microsurgical instruments such as micro bayonet and microscissors. A sufficient microsurgical technique should not cause any pial tissue injury.

The identification of the middle cerebral artery is easy to recognize and dissection. On the other hand dissection of the venous structure is difficult in cadaveric cow brain specimens. The suitability of the experiment for training model was evaluated as bad in (2) 20% of the fresh cadaveric cow brains. The suitability was found as good in (6) 60% of the procedures. In the remaining (2) 20% of the brain dissection, the suitability of the experiment was evaluated as perfect.

Discussion

Regional microsurgical anatomy includes sulcus and cisterns. Microsurgical instruments should be well-known and recognized for a safe micro-neurosurgical intervention and gained practice [3]. It is also crucially important the using of these instruments with appropriate microsurgical technique [3]. Sylvian cistern is the most well-known neuroanatomical structure among the neurosurgeons. This cistern is transitional between the basal cisterns and the subarachnoid space over the convexities [7]. Sylvian cistern is a convenient corridor in the reaching down to the cranial base such as sellar region, olfactory groove, optic chiasm, and carotid-cavernous structures. On the other hand, the most medial and inferior extent of the Sylvian cistern is at the origin of the middle cerebral artery from the internal carotid [7]. The Sylvian cistern contains the middle cerebral artery and the origin of the lenticulostriate, temporopolar and anterior temporal arteries, the middle cerebral artery bifurcation and the origins of the major branches [7]. The superficial and deep Sylvian veins are also within the cistern [7]. Dissection of the Sylvian cistern should be started with the opening of the arachnoid membrane overlying the cisternae distal to the middle cerebral artery bifurcation and superior to the temporal veins. After finding the distal part of the middle cerebral artery branches, the dissection should be directed to the bifurcation and proximal part of the middle cerebral artery. Separation and retraction of the frontal and temporal structures are necessary for the keep progressing down to the proximal part of the cistern.

Before a real operation performing on human beings, it is extremely necessary that understanding of the capability of some metallic surgical devices to be used in the micro-neurosurgical intervention. It is required for the person to develop his or her own abilities and to create integrated personal surgical techniques for the appropriate protection of brain [1, 5, 6]. It is extremely imperative that surgical techniques should be repeated several times on appropriate models to maintain and terminate microsurgical interventions successfully [6]. Vascular end-to-end, end-to-side, side-to-side anastomosis, aneurysm clipping, and Sylvian fissure dissection may be practiced using similar training models [1, 2, 4, 5].

In this experimental model, fresh cadaveric cow brains were evaluated for its suitability as a training model for Sylvian cistern microsurgical dissection. An appropriate and successful model should have some similarities with the represented human organ or system. Ethical issues with live models in addition to the above disadvantages also pose problematic limitations in experimental practice.

There are a few differences between the human and cow brain. The human brain is larger in size and shape when compared to the cow’s brain. The cow brain does not have as many gyri and sulci when compared to human brain. A cow’s brain is elongated in shape, whereas a human brain is rounded. The human brain is not only larger but also heavier than a cow’s brain. However, there are some differences between human and cow brains, but almost all mammals brain are similar. Except for some anatomical differences, the location of the interhemispheric sulcus and the arachnoid membrane have the same characteristic feature between human and cow brain. In this experimental model, the similar microsurgical instruments were used during dissection, separation, and distraction of the brain. Micro scissor, the tip of the micro-suction tube and micro bayonet were used in the dissection and separation of the neural and vascular structures.

It can be seen some advantages when we evaluate the cow brain under the light of the parameters detailed above. Because the fresh cadaveric cow brain is not a living model, there is no need for local ethical committee permission. So there are no ethical restrictions in this model in comparison with live models. In addition to ethical convenience and the intense similarities with the human brain, the fresh cadaveric cow brain was used in this study. When we think of all these features together, the cow brain should be regarded as a suitable model in the experimental micro-neurosurgical training for Sylvian cistern dissection.

Sulcus and/or cisternae dissection and separation in the microsurgical brain operation is commonly used in micro-neurosurgical practice. Performing of the finely locate the lesion using neuroradiological images can be performed during the surgical intervention. Following the cisternae dissection and/or splitting of the brain parenchyma, operative corridor may be reached down and pathology localized or located inside the Sylvian cistern. Repetitive training of the Sylvian cistern dissection in the models like ours is crucial in improving safety in microsurgical intervention. This experimental study revealed that cow brain is a suitable model for training in Sylvian cistern dissection. The suitability was found as good in (6) 60% of the procedures and perfect in (2) 20% of the procedures. Cow Sylvian cistern dissection may be used for training in Sylvian cistern and middle cerebral artery dissection.

Conclusion

To sum up, safe surgical interventions require protecting of the brain tissue and neurovascular structures. Thus, it’s extremely necessary to perform dissection and separation on neurovascular on training models before real practices on humans. Cow’s Sylvian cistern training model is feasible as shown in this experimental study. We believe that this training model will contribute to the practical micro-neurosurgery in various terms primarily, it helps to protect neurovascular tissue. Additionally, it provides adequate performance for the microsurgical intervention around the Sylvian cistern.

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Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

References

1. Altunrende ME, Hamamcioglu MK, Hıcdonmez T, Akcakaya MO, Bırgılı B, Cobanoglu S. Microsurgical training model for residents to approach to the orbit and the optic nerve in fresh cadaveric sheep cranium. J Neurosci Rural Pract. 2014; 5(2): 151-4.

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4. Turan SH, Ceylan D, Tatarlı N, Hıcdonmez T, Seker A, Bayrı Y, et al. Laboratory training in the retrosigmoid approach using cadaveric silicone injected cow brain. Br J Neurosurg. 2013; 27: 812-4.

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Ahmet Gokyar, Enis Kuruoglu, Cengiz Cokluk. The Use Of Fresh Cadaveric Cow Brain As An Experimental Model For Sylvian Fissure Microdissection. J Clin Anal Med. 2018;9(1):61-64

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Higher levels of CD19+ leukocytes in Gaucher disease patients as a potential marker for malignancy

Meral Dondurmacı 1, Ebru Canda 2, Melis Köse 3, Sema Kalkan Uçar 2, Mahmut Çoker 2, Ferhan Sağın 1, Eser Y. Sözmen 1

1 Department of Medical Biochemistry, Ege University Faculty of Medicine, 2 Department of Inherited Metabolic Disease, Ege University Faculty of Medicine, 3 Department of Inherited Metabolic Disease, Behçet Uz Children’s Hospital, İzmir, Turkey

DOI: 10.4328/JCAM.5418 Received: 11.10.2017 Accepted: 12.11.2017 Published Online: 12.11.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 56-60

Corresponding Author: Eser Y. Sozmen, Department of Medical Biochemistry, Ege University Faculty of Medicine, Bornova, İzmir, 35100 Turkey. T.: +90 2323904098 F.: +90 2323904030 E-Mail: eser.sozmen@ege.edu.tr; esersoz@yahoo.com

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Aim: Gaucher disease is an autosomal recessive lysosomal storage disease caused by insufficient glucocerebrosidase activity resulting in accumulation of glu-cosylceramide, particularly in macrophages. Multiple myeloma and B cell lymphoma are considered to be one of the causes of death from GD in the long term. We aimed to compare cell surface antigens of leukocytes to try to identify a reliable marker for leukocyte infiltration and progression to lymphoid malignancy. Material ve Method: 10 Gaucher disease patients and 20 age-matched healthy controls were included. Leukocytes were collected from whole blood using a Ficoll gradient, stained for specific cell surface antigens (CD33, CD19, CD14, and CD8) and sorted by flow cytometry. Levels of each leukocyte cell surface antigen were expressed as a percentage of leukocytes expressing them. Leukocyte glucocerebrosidase activity was measured by fluorometry. Results: The percentage of CD19+ leukocytes in Gaucher disease patients (8.2 ± 3.4) was significantly higher than in the control group (4.8 ± 3.4) (p<0.05). The percentage of leukocytes expressing CD33 (12.8 ± 6.6 vs 7.9 ± 8.0, p=0.077), CD14 (10.6 ± 4.6 vs 7.1 ± 6.9, p=0.094) or CD8 (12.7 ± 5.3 vs 9.8 ± 5.9, p=0.115) was not significantly higher in patients than in controls. Discussion: The higher levels of CD19+ leukocytes may serve as a useful marker to predict leukocyte infiltration and perhaps also malignancy in Gaucher disease patients. Experimental anti-CD19 drugs are in development for the treatment of B cell cancers, and CD19+ leukocyte levels may also serve as a marker of the response to this treatment.

Keywords: Gaucher Disease; Leucocyte Cell Surface Antigens; CD19+; Multiple Myeloma; Leucocyte Infiltration; Flow Cytometry

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Introduction

Gaucher disease (GD) is an autosomal recessive lysosomal storage disease caused by insufficient glucocerebrosidase activity resulting in cellular accumulation of glucosylceramide, particularly in leukocytes and of them especially in macrophages. The patients manifest a wide variety of signs from delayed growth to neurologic symptoms. Thus, the disease can be classified as non-neuronopathic (Type 1) or neuronopathic (Types 2 and 3). The majority (95% of cases) is Type 1 GD patients with splenomegaly, hepatomegaly, anemia, thrombocytopenia, bone disease and delayed growth. Type 2 is the fatal form that is characterized by a fast brainstem degeneration and irresponsiveness to treatment. Type 3 manifests with neurologic symptoms and limited lifespan (<30 years) [1]. The current treatment of GD is based on enzyme replacement therapy (ERT), imiglucerase and follow-up studies show that the response is maintained only when the ERT is administered every two weeks [2].

Lysosomal accumulation of b-glucosylceramide and its deacylated product, glucosylsphingosine is associated with chronic inflammation and B-cell activation, often manifested by polyclonal and monoclonal gammopathy [3,4]. Several possible contributing factors like gene modifiers, splenectomy and immune system deregulation induced by cytokines, chemokines, and hydrolases released from Gaucher cells have also been proposed for increased B-cell proliferation and neoplasia in GD. A greater incidence of B cell non-Hodgkin lymphoma and some other hematologic malignancies (multiple myeloma, plasma cell malignancies, hepatocellular carcinoma) in GD patients has recently been reported [5] and the triggering role of bioactive sphingolipids on the known clonal expansion of immunoglobulin-secreting B cells and the pathogenesis of multiple myeloma has been investigated [6,7]. Multiple myeloma and B cell lymphoma are suspected to be the leading causes of death in GD patients over the long term [5,8].

B-lymphocyte antigen CD19 is a glycoprotein expressed on B cells and is present from the earliest recognizable B-lineage cells during development to B cell blasts, but is lost on maturation to plasma cells. Since CD19 is a hallmark of B cells, the protein has been used to diagnose cancers that arise from this type of cell, notably B cell lymphomas [9]. Other related antigens include: CD33, which is usually considered to be a myeloid-specific transmembrane receptor expressed on cells of myeloid lineage; CD14, which serves as a co-receptor for the detection of bacterial lipopolysaccharide; and CD8, which is a transmembrane glycoprotein predominantly expressed on the surface of cytotoxic T cells and serves as a co-receptor for the T cell receptor.

In this preliminary study, our aim was to compare the expression of leukocyte cell surface antigens in GD patients and healthy controls and glicocerebrosidase enzyme activity in the specific leucocytes sorted by flow cytometry, in order to investigate possible relationship between the disease severity and leucocyte antigens in the hope of finding a reliable marker for leukocyte infiltration and progression to lymphoid malignancy in GD.

Material and Method

Patients

Ten patients with genetically verified GD Type 1 and Type 3 (3 males and 7 females, 3–40 years of age) and 20 age-matched healthy controls (8 males and 12 females) were included in this study. The protocol was approved by the Ethical Committee of the Ege University School of Medicine (13-3.1/4, 19.03.2013). Informed consent was obtained from all participants and the legal guardians of the children included in the study.

Sample collection and processing

We collected 8 mL of whole blood from patients just before they received enzyme replacement therapy and from controls. Blood was anticoagulated with EDTA. Leukocytes were separated manually using a Ficoll gradient.

Flow cytometry

The leukocytes were labelled with different dye-labelled antibodies specific for each of four cell surface antigens (CD14, CD8, CD33 and CD19) as follows: CD14 was stained with peridinin chlorophyll protein (PerCP)-Cy5-5-labeled anti-CD14; CD8 with phycoerythrin (PE)Cy7-A-labeled anti-CD8; CD33 with fluorescein isothiocyanate (FITC)-A-labeled anti-CD33 and CD19 with PE-A-labeled anti-CD19 (all labelled antibodies were purchased from BD Biosciences). The cells were sorted by flow cytometry, and the leukocytes positive for CD33, CD19, CD14, and CD8 were collected. Figure.1 presents the distribution of leukocytes positive for signed antigens.

Measurement of glucocerebrosidase activity

Glucocerebrosidase enzyme activity (nmol/h/mg protein) was determined fluorometrically in the leukocyte samples after sorting by the method of Chamoles et al. [10] with sample blank correction [11]. Briefly, 5 μl of leukocyte for each measurement were placed in a 96-well microplate. After the addition of an elution buffer (Na-taurodeoxycholate) and substrate (4-Methylumbelliferyl -β-D-glucopyranoside, 20 M, pH=4.4) to the well, the samples were incubated for 1h at 37oC. The reactions were stopped by adding 200 microliters of 0.1M ethylenediamine. All readings (excitation 365nm and emission 450nm) were performed on a Modulus microplate fluorometer (Turner Biosystems), and all calculations were performed using a calibration curve of 4-methylumbelliferone as the calibrator. Leukocyte samples from a healthy person and a confirmed patient (randomly selected) were used as positive and negative controls in each assay run. The protein levels of the leukocytes were determined by the Lowry method [12].

Statistical analysis

All data were evaluated using the SPSS 17.0 statistics program. Mann-Whitney U test was used to compare mean enzyme activity between the groups. Correlation analysis was performed using Spearman’s correlation test.

Results

Eight of 10 patients were under enzyme replacement therapy (mean treatment duration was 6.1± 3.3 years) and 2 of them were newly diagnosed. Five patients had hepatomegaly, and 9 patients had splenomegaly, none of them have neurologic symptom/signs. The routine biochemical parameters (glucose, SGOT, SGPT, ALP, LDH, phosphorus) of patients were in the normal levels; serum calcium levels were in lower limits (8.6 ± 3.0, reference interval 8.6-10.2). The Z-score (L1-4) of patients were low (-0.63 ± 0.38) indicated secondary osteoporosis.

There was no statistically significant difference between the ages of patients in the GD group (22.2 ± 13.2) and control group (27.3 ± 3.2) (p>0.05). The leucocyte glucocerebrosidase activity of patients were lower than those of controls (1327±1448 nmol/mg protein vs. 372±465 nmol/mg protein).

Comparison of levels of each leukocyte cell surface antigen between GD patients and healthy controls is expressed as a percentage (Table 1). We found that the percentage of leukocytes bearing the CD33, CD14 and CD8 cell surface antigens were higher in GD patients than in the control group but the difference was not statistically significant. Only the percentage of CD19-positive (CD19+) leukocytes was significantly higher in GD patients than in the control group (p<0.05). We determined significantly positive correlations between the percentage of different leucocytes in controls, no correlation determined in the patient group.

The glucocerebrosidase activities in the sorted leukocytes positive for CD33, CD19, CD14, and CD8 of GD patients were lower than those of controls. While the enzyme activity in the different type of leucocytes (CD33+, CD19+, and CD14+) of healthy controls positively correlated with each other (Table.2), there was no correlation in patient’s leucocytes.

Discussion

We aimed to investigate the percentage of leukocytes having specific cell surface antigens (CD33, CD19, CD14, and CD8) and the glucocerebrosidase enzyme activity of these leukocytes in patients with GD. Our data indicated higher numbers of CD19+ leukocytes, and this may serve as a useful marker to predict leukocyte infiltration in GD patients.

Many authors [6,7, 13] have reported a higher prevalance of various types of cancer in GD patients; however, in a report from the International Gaucher Registry using data collected from their database including 2742 patients from more than 40 countries, the overall relative risk of cancer (breast, prostate, colon and rectum, lung, and hematologic malignancies other than myeloma) was 0.79 (95% CI: 0.67, 0.94), which does not reflect a statistically significant higher risk for GD patients. On the other hand, this study found that multiple myeloma incidence was 5- to 9-fold higher in GD patients than in the general population [8].

Various explanations have been proposed for the higher incidence of multiple myeloma in GD patients. One is related to the carcinogenic effect of sphingosine derived from glucosylsphingosine [14]; accumulated glycosylceramide becomes acylated to glucosylsphingosine, which might diffuse into the cytosol [6]. However, this hypothesis is unlikely because enzyme replacement therapy did not prevent lymphoma in these patients.

Another hypothesis is associated with the elevated levels of pro-inflammatory cytokines and chemokines through activation of macrophages by glucosylceramide accumulated within them [7, 15,16]. Chitotriosidase is a macrophage activation marker known to be higher in GD patients, and our data consistently showed higher chitotriosidase activity in these patients. Some investigations reported higher levels of cytokines IL-6 and CCL-18 in GD, which promote gammopathies [17, 18]. Cox et al. pointed out that higher levels of cytokines, in particular, IL-6, might be responsible for chronic B cell stimulation and monoclonal gammopathy in GD [5].

Given that it has been presented that the plasma cells in B cell lymphomas express CD19 and/or CD4 [19], we determined the proportion of leukocytes expressing these antigens in GD patients. CD19 plays a major role in the B cell surface signal transduction complex and is expressed on mature B cells. Recently, it has been shown that there is a higher expression of CD19 in B cell malignancies such as acute lymphocytic leukemia (ALL), B cell non-Hodgkin lymphoma and chronic lymphocytic leukemia, but no expression in non-haematopoetic cells and other hematopoietic populations [9]. Pandey et al. [16] reported higher levels of chemokines and CD19+ leukocytes in the mouse model of GD. Marti et al. [3] showed high levels of CD19 leucocytes in 7/7 Gaucher patients, in accordance with our findings that is a higher number of CD19+ leukocytes in GD patients, which might predict hematologic malignancies. Recently, CD19 chimeric antigen receptor (CAR) directed T cells have shown very favorable clinical results in a range of B cell malignancies, even in patients with chemorefractory relapse [9]. Keeping in mind that CD19+ is an ideal CAR target, increased CD19+ expression in GD patients in our study may also provoke new clinical studies in which CAR therapy can be used in GD patients with B cell malignancies.

Our data showed no significant difference in CD8+, CD14+ and CD33+ leukocytes between GD patients and healthy controls, in accordance with the literature, which found a close association between these markers and the severity and/or prognosis of disease but not a diagnosis in multiple myeloma patients [20,21,22]. Because the occurrence of T cell lymphomas in a few patients with GD type 1 has been reported [20], we investigated the levels of CD8+ leukocytes (T-cytotoxic cells) and found them to be similar to those of healthy individuals. However, Lacerda et al. reported T cell deficiency as well as deficiency in CD8+ T cell subsets in GD patients, and this depletion was found to be related to sequestration in the spleen and improvement of bone pathology [23]. In our study, none of the patients had a splenectomy, 9 of them had a splenomegaly; therefore the percentage of CD8+ leucocytes remained into normal levels.

Shim et al. reported that immature and plasmablastic types of plasma cells were significantly associated with CD33 positivity [21], thus in our study, we also determined CD33 expressing leukocyte as a marker of the myeloid lineage in GD patients. Our data showed no significant difference in the proportion of CD33+ leukocytes in patients compared with controls, probably due to the absence of any type of lymphoma at the time of the study. We do not know if these patients will develop multiple myeloma in their lifetime, so we cannot conclude whether CD33+ might be a reliable marker for hematologic malignancies in the GD patient. As it has been shown that CD33 expression was an independent prognostic factor for poor prognosis in multiple myeloma [21], we can suggest that CD33 might be a prognostic rather than a predictive marker for further hematologic malignancy.

The main limitations of this study are both the study design (cross-sectional) and the limited number of patients. Nevertheless, since GD is a rare metabolic disease, we considered our results as an important initial data that deserves to be reported.

We have found higher levels of CD19+ leukocytes in GD patients than in healthy controls. We conclude that higher levels of CD19 antigen expression supports the inflammatory activation hypothesis which might play a role in the development of B cell-derived malignancies. We suggest that higher CD19+ leukocyte levels may also serve as a marker to predict malignancy in these patients. To test this hypothesis, our group currently is further monitoring these patients for long-term survival and complications.

Scientiﬁc Responsibility Statement

Animal and human rights statement

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

References

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2. Souza AMA, Muniz TP, Brito RM. Study of enzyme replacement therapy for Gaucher Disease: comparative analysis of clinical and laboratory parameters at diagnosis and after two, five and ten years of treatment. Rev Bras Hematol Hemoter. 2014; 36(5): 345–50.

3.Marti GE, Ryan ET, Papadopoulos NM, Filling-Katz M, Barton N, Fleischer TA, et al. Polyclonal B-cell lymphocytosis and hypergammaglobulinemia in patients with Gaucher disease. Am J Haematol. 1988; 29: 189-94.

4.de Fost M, Out TA, de Wilde FA, Tjin EP, Pals ST, van Oers MH, et al. Immunoglobulin and free light chain abnormalities in Gaucher disease type I: data from an adult cohort of 63 patients and review of the literature. Ann Hematol. 2008; 87(6):439-49.

5.Cox TM, Rosenbloom BE, Barker RA. Gaucher disease and comorbidities: B-cell malignancy and parkinsonism. Am J Hematol. 2015; 90: S25–8.

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Meral Dondurmacı, Ebru Canda, Melis Köse, Sema Kalkan Uçar, Mahmut Çoker, Ferhan Sağın, Eser Y. Sözmen. Higher levels of cd19 leukocytes in Gaucher disease patients as a potential marker for malignancy. J Clin Anal Med. 2018;9(1):56-60

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Evaluation of great saphenous vein variations with color doppler ultrasonography

Omer Kaya 1, Cengiz Yilmaz 1, Bozkurt Gulek 1, Kaan Esen 2, Gokhan Soker 1, Okan Dilek 1, Mehmet Ali Akin 1

1 Department of Radiology, University of Health Sciences, Adana Numune Teaching and Research Hospital, Adana, 2 Department of Radiology, Mersin University, Faculty of Medicine, Mersin, Turkey

DOI: 10.4328/JCAM.5417 Received: 04.10.2017 Accepted: 13.11.2017 Published Online: 13.11.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 51-5

Corresponding Author: Omer Kaya, Department of Radiology, University of Health Sciences, Adana Numune Teaching and Research Hospital, Adana, Turkey. E-Mail: dr.omerkaya@gmail.com

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Aim: The evaluation of venous structures using color doppler ultrasonography (CDUS) has a distinctive place in both diagnosis and treatment. Because venous structures demonstrate a wide range of variations, it is important to have a good knowledge about these variations, to improve the diagnosis and treatment efficacy. The purpose of this study was to evaluate anatomic variations of the great saphenous vein (GSV). Material and Method: In this study, 500 GSVs of 250 patients who had applied to the radiology department of the Adana Numune Teaching and Research Hospital between July 2013 and October 2014, were examined by CDUS. 54 patients were males, and 196 were females. The age spectrum was 17 – 48 years and the mean age was 33.3 ± 8.0 (sd). Statistical analyses were percentage ratios and standard deviations (sd). For this study, linear transducers with a frequency range of 7.5 – 13.0 MHz, were used. Results: In the study, 4 variations at the thigh level, 5 variations at the knee level and 3 variations at the leg level, were detected. All variations were described and given with their percentages. Discussion: The anatomic variations of the GSV and their frequencies were studied. Due to its simplicity, cheapness, and effectivity, CDUS has been widely preferred for the examination and evaluation of venous structures, and it has a unique place in the diagnosis of situations concerning these vessels.

Keywords: Great Saphenous Vein; Variation; Doppler Ultrasonography

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Introduction

The GSV is the longest vein in our body, and it plays the biggest role in the venous drainage of the lower extremities. CDUS is the fundamental method of choice in the evaluation of lower extremity venous structures, and it is widely used as a simple, cheap, easy, and effective means, especially in defining the varicose alterations of these structures [1,2].

The superficial veins may have many branches, and sometimes they may demonstrate collaterals. Superficial venous structures may show variations which differ for each person [3]. It has been shown by many recent studies that lower extremity veins may demonstrate a wide range of variations including mainly the presence of accessory veins and branchings [4]. Possessing a thorough knowledge of these variations is not only essential in the defining of venous pathologies, but also of utmost importance for proper planning and execution of minimally invasive therapeutic alternatives.

The purpose of this study was to detect and define the anatomic variations of the GSV.

Material and Method

This retrospective study was conducted at the radiology department of University of Health Science, Adana Numune Teaching, and Research Hospital, and it comprises cases examined between July 2013 and October 2014. The patients were evaluated in terms of variations of the great saphenous vein. The study is statistically a descriptive work.

500 legs of 250 patients were included in the study. Each lower extremity was considered as an individual case. The patients were randomly selected and composed of 54 males and 196 females. All patients applied to the radiology department for CDUS examinations of their lower extremity veins. The majority of the patients had venous insufficiency symptoms, while some presented with leg pain, swelling, and edema. No patient had a history of GSV surgery, and this was the selection criteria to include the patients into the study.

CDUS Technique

The examinations were performed with 7.5 – 13 MHz transducers of three different brands of US machines. These were the Mindray DC – 7, GE Logiq P 6, and Toshiba Aplio MX, devices. All evaluations were started at the SFJs and completed at the very distal ends of the vein tracts. All branching variations detected at the thigh, knee, and leg levels were recorded.

Evaluation

The anatomic variations of 500 GSVs at the thigh, knee, and leg levels were defined, and their frequencies were cited. The study is descriptive in statistical terms. Thus, there is no control group. Due to the study’s descriptive nature, no experimental or interventional methods were utilized. Percentage ratios and standard deviations (sd) were used for statistical evaluations of the findings.

Results

The Demographic Properties of the Patients

The mean age of the 250 patients included in the study was 33.3 ± 8.0 (sd) years, and the age range was 17 – 48 years. 54 patients were males, and 196 were females. The male / female ratio was 1 / 3.6. Patients were most frequently referred from cardiovascular and general surgery clinics.

Variations Demonstrated at the Thigh Level

Examinations of the 500 legs of 250 patients in our study disclosed all four but one variations described in the literature, this exception being the duplication variation. The frequencies of these four variations were as follows:

a) 48 GSVs were found to be coursing in the saphenous compartment, without any branchings (% 9.6) (Fig.1).

Fig 1. US image of great saphenous vein just before saphenofemoral junction without any branch. Also seen femoral vein (arrow: femoral vein, arrowhead: GSV).

b) A large branch which was not located in the saphenous compartment and which penetrated this compartment at some level, was found in 281 cases (%56,2) (Fig.2).

Fig 2. A tributary vein which was not located in the saphenous compartment draining to great saphaneus vein at some level of thigh (arrow: GSV, arrowhead: tributary vein).

c) In 148 cases, there were a GSV and anterior accessory saphenous vein (AASV) in the distal saphenous compartment, and these vessels were creating two distinct “eye signs” (Fig.3). Also, these veins were uniting to form a single vessel prior to joining the SFJ (%29,6)

Fig 3. GSV and AASV seen in two separate saphenous compartmant at the level of the distal thigh (arrow: GSV, arrow head: AASV).

d) A branch which was not located in the saphenous compartment was found to be draining into the GSV just before the SFJ, in 23 cases (%4,6) (Fig.4).

Fig 4. US image of a tributary vein draining to great saphaneus vein before saphenofemoral junction (arrow: GSV, arrowhead: tributary vein).

The thigh-level GSV variations of the 54 male and 196 female patients are listed in Table 1.

Variations Detected at the Knee Level

Following the evaluation of the 500 GSVs, all of the 5 variation patterns described in the literature were found in our patients. These variations were as follows:

a) In the knee level, GSV was found without any branchings in 126 cases (%25,2) (Fig 5).

Fig 5. Great saphaneus vein at the knee level without any branching (arrow).

b) One or two tributary veins draining into the GSV below the knee were detected in 144 cases (%28,8) (Fig 6).

Fig 6. US image of a tributary vein and GSV below the knee (arrow: BSV, arrowhead: tributary vein).

c) A normally calibrated or varicose tributary vein was found to be draining into the GSV in 105 cases (%21,0) (Fig 7).

Fig 7. US image of a tributary vein and GSV at the knee level (arrow: BSV, arrowhead: tributary vein).

d) In 59 cases, the GSV was not visible at the knee level, and a subcutaneous tributary vein penetrating the fascia was found to be connecting the proximal and distal portions of the GSV (%11,8) (Fig 8).

e) In 66 cases, the pattern was very much similar to the one described above, except for the fact that the invisible GSV compartment was very short in these cases (%13,2).

The knee-level variations of the 54 male and 196 female patients are listed in Table 2.

Fig 8. US image shows a superficial and subcutaneous tributary vein which is seen at the knee region (arrow), where GSV is not observed in the saphenous compartment.

Variations Detected at the Leg Level

After examining and evaluating all of the 500 GSVs, it was found that all 3 of the leg-level variations reported in the literature were present in our group too. These variations and their frequencies were as follows (Fig 9):

Fig 9. US images of variations at leg level;

A) I type: A single GSV is in saphenous compartment without branching (arrow)

B) H type: GSV in the saphenous compartment (arrow) and it’s branch out of the compartmant (arrowhead)

C) S type: In this image which shows the middle part of leg, GSV is not visiable, but there is a tributary vein which is not in the saphenous compartment (arrow).

• I Type: A single GSV was found in 225 cases, coursing through the saphenous compartment with no distinct branching (%45,0).

• H Type: In 241 cases, a branch usually larger than the GSV itself was found to be coursing outside the saphenous compartment and draining into the GSV after penetrating the fascia (%48,2).

• S Type: A superficial branching was detected in 34 cases, which was penetrating the fascia and draining into the GSV. But a distinct feature was that the GSV was invisible beyond this level, and thus it was considered as hypoplastic or aplastic (%6,8).

The leg-level GSV variations seen in the 54 male and 196 female patients are listed in Table 3.

Comparison of variations for right and left lower extremities

The variation ratios for the right and left extremities in each 3 levels are listed in table 4.

Discussion

The GSV is the largest vein of the human body [5]. The vein courses along the medial aspects of the lower extremities [6]. The evaluation of the vein is usually accomplished using CDUS, which is a cheap but very effective modality in this aspect. Particularly, the vein’s location inside the saphenous compartment and “Egyptian-eye” pattern caused by this location, are very typical of this vein, and thus, contribute to the practicality of this modality in the overall evaluation of the vessel [7,8].

Various anatomical variations may be encountered at the thigh, knee, and leg levels of the GSV tract. A good command of knowledge concerning these variations is mandatory for a thorough examination of the vessel anatomy and pathology, and also for a successful therapy [9].

Various anatomic variations of the GSV have been reported in the literature, at three levels of the vein tract. These are the thigh, knee, and leg levels [8]. Five variations have been defined at the thigh level, while four have been reported at both the knee and leg levels each. Many scientific reports in the literature have defined the frequencies of variations encountered in the knee region, but sufficient data is missing about the frequencies of variations seen at the thigh and leg levels [8,9,10]. A previous study evaluated a large series of the variations in the knee region [11], and results were similar to ours. In our study, substantial data is being given about the frequencies of variations concerning all of these three levels.

Two hundred and fifty patients were included in our study. Five hundred GSVs of these patients were examined, and each lower extremity was considered as an individual case. Our study has a substantial number of patients when compared to most of the reports in the literature. 54 of these 250 patients were males, while 196 were females. The mean age of the patients was 33.3 ± 8.0 (sd) years.

In the previous studies, the ratios of variations between the men and women are not defined on 3 levels of lower extremity. Therefore, a comparison could not be made with the literature. In our study, there was no significant difference in the thigh and knee regions about the variations between males and females. However, with minor differences between genders, the type I variation at the leg level was %51 in males and %43.4 in females, S type variation was % 2.8 in males and % 7.9 in females. These findings suggest that gender differences, especially for the leg level, can be about GSV variations and this must be kept in mind in diagnostic and therapeutic evaluations.

Also, the frequency of variations were compared according to the right and left lower extremities. There was no significant difference in all the variations at each 3 levels of extremities. Also, except S type variation of the leg, variations of an extremity was generally the same on the opposite extremity. However, S type variation of the leg was detected bilaterally in only 2 patients. According to findings, it should be taken into consideration while evaluating a patient, that especially the leg level variations may be different for both extremities.

It has been reported that a true duplication of the GSV is a very rare event [8,9,12,13]. This rare variation was not encountered in any of our cases.

Because of the lack of a thorough descriptive study reporting the variation frequencies of the GSV at all of these three levels, a satisfying comparison of our study results with those from the literature seems out of reach for the moment. But, some studies in the literature have reported rather similar frequencies of variations encountered at the knee level, and thus, our results concerning the same level could be compared with those findings. These comparisons disclosed similar results demonstrating harmony with those from the literature [8,9].

Conclusion

The results of our study clearly show that the GSV has a large number of variations at various levels of its track. A good knowledge of these variations is of utmost importance not only for a proper CDUS evaluation and diagnosis but also for a successful intervention to be performed by interventional radiologists.

Scientiﬁc Responsibility Statement

Animal and human rights statement

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

References

1. Coleridge-Smith P, Labropoulos N, Partsch H, Myers K, Nicolaides A, Cavezzi A. Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs-UIP consensus document. Part I. Basic principles. Eur J Vasc Endovasc Surg. 2006;31(1):83-92.

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3. Caggiati A, Bergan JJ, Gloviczki P, Jantet G, Wendell-Smith CP, Partsch H, et al. Nomenclature of the veins of the lower limbs: an international interdisciplinary consensus statement. J Vasc Surg. 2002;36(2):416-22.

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5. Caggiati A. The saphenous venous compartments. Surg Radiol Anat. 1999;21(1):29-34.

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7. Bailly M. Cartographie CHIVA. Enclyclopedie Medico-Chirurgicale. Paris; 1993: 43–161-B: 1–4.

8. Cavezzi A, Labropoulos N, Partsch H, Ricci S, Caggiati A, Myers K, et al. Duplex Ultrasound Investigation of the Veins in Chronic Venous Disease of the Lower Limbs—UIP Consensus Document. Part II. Anatomy. Vasa. 2007;36(1): 62-71.

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10. Caggiati A, Ricci S. The caliber of the human long saphenous vein and its congenital variations. Ann Anat. 2000;182(2):195-201.

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12. Ricci S, Caggiati A. Does a double saphenous vein exist? Phlebology. 1999;14(2):59-64.

13. Zamboni P, Cappelli M, Marcellino MG, Murgia AP, Pisano L, Fabi P. Does a varicose saphenous vein exist? Phlebology. 1997;12(2):74-7.

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Omer Kaya, Cengiz Yilmaz, Bozkurt Gulek, Kaan Esen, Gokhan Soker, Okan Dilek, Mehmet Ali Akin. Evaluation of great saphenous vein variations with color doppler ultrasonography. J Clin Anal Med. 2018;9(1):51-55

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Diagnostic value of procalcitonin, C-reactive protein, and erythrocyte sedimentation rate for acute complicated appendicitis

Lutfi Soylu, Oguz Ugur Aydin, Mehmet Yıldız

Departments of General Surgery, Ankara Guven Hospital, Ankara, Turkey

DOI: 10.4328/JCAM.5414 Received: 03.10.17 Accepted: 08.11.2017 Published Online: 08.11.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 47-50

Corresponding Author: Lutfi Soylu, Department of General Surgery, Ankara Guven Hospital, Simsek Sokak, 06540, Kavaklidere, Ankara, Turkey. T.: +90 3124572473 F.: +90 3124572886 E-Mail: lutfisoylu@hotmail.com

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Abstract

Aim: Acute appendicitis (AA) is one of the most common surgical emergencies. Despite extraordinary advances in modern investigations, an accurate diagnosis of AA remains an enigmatic challenge. The purpose of this study was to examine the laboratory parameters studied during the preoperative period in patients who were histopathologically diagnosed with AA; C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and procalcitonin (PCT) in the differential diagnosis of complicated/uncomplicated appendicitis. Material and Method: This study included 106 patients, separated into two main groups; the uncompli-cated appendicitis group (n = 74) and complicated appendicitis group (n = 32). The CRP, ESR, and PCT levels were calculated for all of the patients in the study. Results: No meaningful differences were observed among the groups, with regards to the sex of the patients. There was, however, a significant difference obtained between the (P> 0.05) CRP, ESR, and PCT values. Serum levels of ESR >31 (AUC = 0.706, P = 0.001, 95% GA: 0.610–0.791), in PCT>1.8 (AUC = 0.709, P = 0.001, 95% GA: 0.568–0.754), and CRP> 56.64 (AUC = 0.700, P <0.001, 95% GA: 0.603–0.785) were obtained. In both complicated appendicitis and uncom-plicated appendicitis analyses, these values were found to be accurate. Using the cut-off values obtained in this study, the ESR, CRP, and PCT serum values, and odds ratios were calculated for complicated appendicitis by classification (odds ratio: 1.042 (0.990–1.097), 1.009 (0.998–1.020), and 2.986 (1.135–7.858), respectively. Discussion: We suggest that with a PCT level>1.8, CRP level>56.64, and ESR level >31, immediate and careful management must be undertaken, as the probability of complicated appendicitis is high.

Keywords: Appendicitis; Inflammatory Markers; Complicated Appendicitis.

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Introduction

Acute appendicitis (AA) is one of the most common abdominal surgical emergencies. After Fitz’s [1] study, in 1886, an early appendectomy became the best-accepted treatment for AA. However, the present recommendation for uncomplicated appendicitis is inoperative management [2–4]. Hence, surgeries should be avoided due to possible complications such as ileus (1.2% of cases) and abdominal hernias (0.68% of cases) [5].

However, complicated appendicitis, like perforated appendicitis and gangrenous appendicitis, have the potential of progressing into acute peritonitis, necessitating emergency surgery. Complicated AA has been observed in 20%–30% of all appendicitis cases [6].

Presently, both clinicians and surgeons are challenged in forming a correct diagnosis and treatment program. It is difficult to form a correct clinical diagnosis of AA, which must be formed using imaging study parameters, and clinical and laboratory results. Although, differentiation between uncomplicated and complicated appendicitis (most often defined as appendicitis with gangrenous change, abscess, or perforation [7], is often difficult, recently, diagnosis accuracy has been improved due to advances in both ultrasound and computed tomography. Diagnostic accuracy increases with the use of multiple markers, which can positively confirm an inflammatory process in the appendix [8].

The purpose of this study was to examine the laboratory parameters studied during the preoperative period of patients who were histopathologically diagnosed with AA; C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and procalcitonin (PCT) in the differential diagnosis of complicated/uncomplicated appendicitis.

Material and Method

We retrospectively evaluated 106 patients who underwent an appendectomy in our general surgery clinic between January 2012 and April 2017. Patients confirmed to have AA by histopathological examination were included in the study. Demographic data that belonged to patients, laboratory parameters, and monitoring examination with histopathology analyzing results were evaluated.

An appendectomy was performed conventionally or laparoscopically. The results of the CRP, ESR, and PCT were evaluated from the laboratory parameters of this disease. Leukocytosis was defined as a white blood cell count (WBC)>10.3 103/μL, and the CRP was considered elevated if the level was >5 mg/L. An outer diameter of the vermiform appendix, measured with ultrasonography (USG), of >6 mm was considered positive for AA. USG assessments were performed with a Toshiba Aplio 300 device (Toshiba Medical Systems Corporation, Otawara, Japan) with a 3.5-MHz transducer.

Patients with acute focal/suppurative appendicitis were placed in the uncomplicated group (Group 1), perimetric abscess with perforated appendicitis were placed in the complicated group (Group 2). Blood samples were taken prior to antibiotic use. Patients were initially evaluated using USG from imaging studies. In patients without appendiceal imaging, computed tomography (CT) was applied with an oral contrast agent application. Patients having a normal abdominal examination, under 16 years of age, pregnant, or on steroids or antibiotics were excluded from the evaluation. All of the patients with sensitivity, defensiveness, and rebound on the right lower side of the abdomen were examined and all of the patients with at least 1 of the laboratory parameters, WBC, CRP, or neutrophil-lymphocyte ratio, were elevated and were above the normal limit of the appendiceal diameter on CT or USG.

Evaluation of the data

Analysis of the data was done using the IBM SPSS 23.0 and MedCalc 15.8 statistical package programs. A chi-square (χ2) test was used to compare the descriptive statistics (frequency, percentage, median, min-max), as well as qualitative data when evaluating the study data. The normal distribution of the data was assessed using the Kolmogorov-Smirnov and Shapiro-Wilk tests, and the data were not normal. In this study, the Mann-Whitney U test was used for a comparison between the groups. The receiver operating characteristic (ROC) curve method was used to determine the variability of the variables, and the binary logistic regression test was used to determine the risk ratios. The likelihood of P-values smaller than α = 0.05 was significant, and there was a difference between the groups, with large values being insignificant and no difference between groups.

Power Analysis: Power analysis G * Power 3.1.9.2 was made with the statistical package program; N1 = 74, n2 = 32, a = 0.05, effect size d = 0.5; power (power (1-beta)) = 0.96.

Results

Among the groups, no statistically significant difference was found regarding the sex of the patients (P> 0.05); however, there was a statistically significant difference found regarding the age values (P <0.05). The age of the group 2 patients were found to be higher. (Table 1)

Among the groups, the ESR, PCT, and CRP values were statistically significant (P <0.05). For the 3 variables, the values of the Group 2 patients were found to be higher than those of the Group 1 patients. (Table 2)

For complicated appendicitis, as a result of the evaluations made by the ROC analysis, cut-off values were obtained for the ESR as >31 (AUC = 0.706, p = 0.001, 95% GA: 0.610–0.791) for the PCT as>1.8 (AUC = 0.709, P = 0.001, 95% GA: 0.568–0.754) and for the CRP as>56.64 (AUC = 0.700, P < 0.001, 95% GA: 0.603–0.785). (Table 3)

Logistic regression analysis was performed to investigate the effects of the variables (ESR, PCT, and CRP), which were found to be statistically significant in the complicated and uncomplicated appendicitis groups, with the occurrence of complicated appendicitis. PCT has been found to be more valuable in diagnosing complicated appendicitis. It was found that there may be about 3 times as many complicated appendicitis patients with an elevated PCT level than those without an elevated PCT level (Table 4)

Discussion

Acute abdomen is commonly caused by AA, bringing about the necessity for immediate surgery, as delays in diagnosis or surgical treatment can result in complications and, in some cases, death. However, not every appendicitis case is surgically treatable, especially cases such as catarrhal appendicitis [9]. Although the use of supportive treatment and antibiotics for managing uncomplicated AA has been supported by several researchers in the literature [10,11]. Often, differentiation between complicated and uncomplicated appendicitis is difficult.

In the literature, in 3 randomized controlled trials, a 1-year cure rate of 74%–87% was reported for uncomplicated appendicitis patients treated with antibiotics; showing that conservative therapy is a possible treatment option for AA patients [10,11].

Recently, confirmation of this was provided by a meta-analysis of randomized controlled trials showing that initial antibiotic treatment for early uncomplicated appendicitis should be considered [12]. That said, delays in surgical treatment remain the main reason for morbidity and mortality, as an exact diagnosis of AA preoperatively is often difficult.

Various laboratory tests can aid in the determination of AA severity. Conventionally, clinical/laboratory parameters, such as body temperature (BT), CRP level, WBC, and neutrophil/lymphocyte ratio (N/L ratio), have been used to differentiate between complicated and uncomplicated appendicitis [13]. A biomarker is an objectively, measurable characteristic which research in the literature has proven is a valid marker of normal physiology, disease, or a disease’s response to treatment [14]. Recently, acute-phase reactants (APRs) have increasingly been used in infection management because these markers are present in the serum, which signifies the presence of inflammation or injury. APRs are a group of heterogeneous plasma proteins which increase or decrease when inflammatory stimuli like infections, trauma, systemic autoimmune disorders, acute arthritis, or neoplasms are present. In the present study, the cut-off values, as well as the laboratory and monitoring parameters, were examined to differentiate between complicated and uncomplicated appendicitis.

In a study by Assicot et al., in 1993, a notable increase in the plasma PCT levels of patients with sepsis or other clinically significant bacterial infections was reported. In cases of sepsis, bacterial inflammation, and multi-organ failure syndrome, PCT is selectively induced. Bacterial endotoxin, which has a half-life of 25–30 h, is the primary trigger. Contrary to CRP, in patients with sterile inflammation or viral infection, the PCT level does not increase [15].

Surgically eliminating inflammatory agents combined with effective antibiotics brings about a decrease in PCT levels [16]. Kafetzis et al. [17] reported that PCT values>0.5 ng/mL are a good indication of the possible development of complications, perforation, or necrotic changes. In the present study, similar results were obtained in the PCT levels in patients with AA who developed complications, as well as in patients with complicated appendicitis.

Currently, in clinical practice, the most commonly used acute-phase markers are the ESR and CRP. Today, the CRP concentration is a widely used indicator in patients suspected of having AA [18]. When diagnosing AA, CRP sensitivity varies between 40%–95.6% and the specificity varies between 53%–82% [19,20].

Yang et al. conducted a study of 897 patients who were assumed to have AA. In their study, the average CRP was found as 39,6 mg/L. For inflated appendicitis, the CRP was 24,1 mg/L, and it was 96,8 mg/L for perforated appendicitis, which was statistically significant [21]. In complicated cases, CRP sensitivity and specificity were higher, which is in line with the findings in the literature [22]. Moreover, the results of our study regarding CRP sensitivity and specificity were also in line with literature (43.8% and 94.6%, respectively).

In the literature, few studies have been performed with regards to the efficacy of ESR for the prediction acute complicated appendicitis. ESR is a non-protein ‘indirect’ APR, which means that it changes according to fluctuations in plasma fibrinogen levels and plasma viscosity [23]. Within 24–48 h of the onset of inflammation, the ESR rises, and as the inflammation subsides, it and slowly returns to a normal level [24]. The results of our study regarding the ESR sensitivity and specificity were also in line with the results in the literature (43.8% and 91.6%, respectively).

In a study by Tanrıkulu et al., examination of the CRP, PCT, and ESR values did not result in a diagnostic value when estimating a normal appendix or AA. However, the PCT and CRP values had a significant impact with regards to the diagnosis of perforated and necrotizing appendicitis, whereas the ESR elevation did not result in similar findings [25].

The stages of AA in the present study were defined based on findings found intraoperatively (peri-appendiceal abscess), macroscopically (resected specimen perforation), and microscopically. In our study, PCT was found to have a similar diagnostic value for complicated appendicitis compared to that of CRP or ESR; however, the PCT value was higher than the other inflammatory indices for the identification of complicated appendicitis.

We should note that this study also had some limitations: 1) It was performed retrospectively. 2) We investigated a relatively small number of patients, young patients and those undergoing conservative treatment were not included, thus limiting the properties of the study.

In conclusion, the PCT, ESR, and CRP levels were statistically different between groups 1 and 2. This allowed us to differentiate complicated and uncomplicated appendicitis between patients more accurately, and better determine the surgical strategy, as well as which medical treatment to apply for those patients with uncomplicated appendicitis. Evaluation of the PCT, ESR, and CRP levels indicated that the inflammation process is a strong prediction of complications such as gangrene, perforation, or abscess.

Ethical Statement

‘All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Scientiﬁc Responsibility Statement

Animal and human rights statement

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

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Lutfi Soylu, Oguz Ugur, Aydin, Mehmet Yildiz. Diagnostic value of procalcitonin, c-reactive protein, and erythrocyte sedimentation rate for acute. J Clin Anal Med. 2018;9(1):47-50

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Comparison of ureteroscopy and percutaneous nephrolithotomy for renal pelvic stones over 2 cm

Faruk Kucukdurmaz 1, Tayfun Sahinkanat 1, Caner Olmez 1, Mithat Temizer 2, Sefa Resim 1

1 Department of Urology, Kahramanmaras Sutcu Imam University, Kahramanmaras, 2 Gaziantep Community Health Center, Gaziantep, Turkey

DOI: 10.4328/JCAM.5404 Received: 26.09.2017 Accepted: 16.11.2017 Published Online:16.11.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 42-6

Corresponding Author: Faruk Kucukdurmaz; Department of Urology, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey. GSM: +905335409307 E-Mail:farukdr@hotmail.com

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Aim: Advances in the technology of ureteroscopes and lithotriptors have led to the implementation of retrograde intrarenal surgery (RIRS) in the treatment of renal Stones. This study aimed to compare the outcomes and complications of semirigid ureterorenoscopy (s-URS) and percutaneous nephrolithotomy (PCNL) for the treatment of renal pelvic stones larger than 2 cm, retrospectively. Material and Method: Between January 2014 and July 2016, 90 patients with single renal pelvic stones of more than 2 cm were treated by PCNL (group 1) or s-URS (group 2). Group 1 had 44; group 2 had 46 patients. Demographic features of patients such as age, gender, body mass index (BMI) as well as stone size were compared. Perioperative course and postoperative outcomes such as stone-free and complication rates were also evaluated. Patients assessed by plain abdominal radiography 24 hours after surgery and non-contrast computed tomography at 3rd months, postoperatively. Clinical success was defined as stone-free status. Results: Mean ages of patients in group 1 and 2 were 40.29±19.78 and 38.41±23.26 year, respectively (p=0.681). Two groups were comparable in terms of gender, BMI, grade of hydronephrosis. Mean stone sizes were also similar. The mean operation, fluoroscopy and hospitalization times were shorter in group 2. After first sessions, mean stone-free rates for PCNL and s-URS were 81.8% and 60.8%, respectively (p=0.037). In the s-URS group,11 patients underwent f-URS due to stone migration into lower calix, and 7 of them became stone-free after those procedures. At 3rd months follow-up, those rates were determined as 84.1% and 76%, respectively. Discussion: Although s-URS is not superior to PCNL in the treatment of large renal pelvic stones, it can be used to reach renal pelvis and fragment those stones in selected cases.

Keywords: Semirigid Ureteroscopy; Percutaneous Nephrolithotomy; Renal Pelvic Stone

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Introduction

Treatment of renal stones has changed considerably from open surgery to minimally invasive procedures in the last decades. However, treatment alternatives may vary concerning stone size and localization. According to European Association of Urology (EAU) Guidelines, first-line treatment option for renal pelvic stones that are larger than 2 cm was accepted as percutaneous nephrolithotomy (PCNL) [1].

Although studies with PCNL reported high stone-free rates (SFR), it is still an invasive procedure with serious complications ranging from mild fever and pain to even death [2,3].

In the recent years, with the aid of technical improvements in ureteroscopes (e.g. small calibers, incorporation of working channels) and advances in intracorporeal lithotripsy, retrograde intrarenal surgery (RIRS) became more popular in the treatment of larger renal stones [4,5].

However, it must be remembered that RIRS procedures were mostly performed with flexible ureteroscopes (f-URS) and those procedures are associated with additional sessions and high rates of fiber breakage which may increase the complication rates and costs of those procedures [6-8].

Although semirigid URS (s-URS) is not accepted as the standard treatment for renal pelvic stones owing to its limited maneuver ability, it can be used to reach renal pelvis without any difficulty in some cases. To date, some studies are reporting the use of rigid or s-URS in the treatment of renal pelvic stones in the literature [9,10]. However, studies comparing the outcomes of s-URS with PCNL and f-URS were limited.

Since data about the use of s-URS in the management of large renal stones were scarce, the present study aimed to evaluate and compare the outcomes of s-URS and PCNL procedures in the management of renal pelvic stones between 2-4 cm, retrospectively.

Material and Method

A retrospective analysis of 90 patients who were treated at our clinic for renal pelvic stones between January 2014 and June 2016 was performed. Non-contrast computerized tomography (CT) and/or intravenous pyelography (IVP) were performed for each patient. Inclusion criteria consisted of the presence of a single renal stone located in the pelvis, stones larger than 2 cm in diameter and for group 2, stones which were accessed safely without any severe resistance to s-URS. Exclusion criteria consisted of the presence of any previous stone treatment, the presence of multiple and/or more complex stones including staghorn ones and any anatomic renal anomaly.

Patients were divided into two categories as PCNL (group 1) and s-URS (group 2). Group 1 included 44; group 2 had 46 patients, respectively. All operations were performed by two surgeons (TS and FK) who were expertised both in PCNL and s-URS. Demographic parameters of patients including age, sex, body mass index (BMI) and stone size were evaluated. Preoperative laboratory tests included serum creatinine and hemoglobin levels, platelet counts, coagulation tests and urine cultures. All patients had a sterile urine culture before the procedures.

Informed consent was obtained from each patient before surgery. Stone size was measured according to EAU guidelines [1].

PCNL technique

Briefly, following the preparation of patients in the lithotomy position, a 6f ureteral catheter was inserted cystoscopically. The patient was taken to the prone position, and access to the kidney was performed under C-arm fluoroscopy using an 18 gauge needle. After that, a guide wire was introduced, and dilatation up to 30F was performed with an Amplatz dilator [11]. Then, the sheath was placed, and by entering with a Storz nephroscope, stones were fragmented with a pneumatic lithotriptor (Vibrolith, Elmed, Ankara, Turkey). Stone fragments were removed with forceps. A 16F nephrostomy tube was placed into renal pelvis in all cases. The operative time was calculated from the insertion of the 6F catheter in the lithotomy position to the final placement of nephrostomy tube.

Semirigid URS technique

First, the patients were placed in the dorsal lithotomy position. An 8.5/11.5F, 42.5-cm-long, semirigid ureteroscope (s-URS) with a 6F working channel (Wolf, Knittlingen, Germany) was used for the procedure.

After visualization of the ureteral orifice, a polytetrafluoroethylene guide was put through the orifice up to renal pelvis, and s-URS was inserted with the guidance of that guide. Ureteral balloon dilation was performed if necessary. We did not try any forceful maneuvers to facilitate access to the renal pelvis in those patients, and when the stones were accessed in the pelvis, they were fragmented by holmium-yttrium-aluminum-garnet (Ho: YAG) laser under direct vision. For laser lithotripsy, Ho: YAG 273 μm laser fiber was used in all cases.

Energy and frequency settings were of 0.8 to 1.2 J and 8 to 10 Hz, respectively. After lithotripsy, stone fragments smaller than 2 mm were left for spontaneous passage. Basket or forceps were used for the removal of larger fragments. A 4.8F Double-J stent was routinely inserted in all patients and removed 21 days after the surgery. Operative time was measured from the insertion of s-URS to the completion of stent placement.

The patients in both groups were compared concerning operation, fluoroscopy and hospitalization times, stone-free, and complication rates. Initial stone-free rates were determined 24 hours after the surgical procedures with a kidney-ureter-bladder (KUB) radiogram. Patients were re-evaluated with KUB or non-contrast computed tomography (CT) if auxiliary procedures necessary at 3 months after the surgery or shock wave lithotripsy. The procedures were considered successful if the patient was stone-free with no residual fragments on radiologic interventions on 3-month follow-up. Complications were recorded according to the modified Clavien classification system [12].

Statistical analysis

Statistical analyses were performed using SPSS 21.0 (SPSS, Chicago, IL, USA). The normality of the distribution of the data for each variable was explored using Kolmogorov-Smirnov test. Data were presented as the mean± standard deviation (SD). Continous variables were compared by using Student’s t and Mann-Whitney U tests as appropriate. Proportions of categorical variables were analyzed by chi-square or Fisher’s exact test. A p value of less than 0.05 was accepted as statistical significance.

Results

Baseline demographic variables were comparable regarding age, gender, BMI, grade of hydronephrosis, laterality and mean stone sizes (Table 1). A sterile urine culture before surgery was asked for each patient.

Perioperative and postoperative data of groups were given in table 2. Mean operative times for PCNL and s-URS groups were 113.41±27.92 (range 70-180) and 90.54±24.13 (range 50-130) min, respectively (p<0.001). Mean fluoroscopy time was significantly longer in PCNL group when compared to s-URS (p<0.001). Mean hospitalization time was significantly longer in PCNL group than s-URS group (2.89±1.11vs. 1.21±1.19 days) (p<0.001).

The stone-free rate was 60.8% for s-URS and 81.8% for PCNL groups after first sessions (p=0.037). Eight and 18 patients had residual stones in PCNL and s-URS groups, respectively. One patient underwent shock wave lithotripsy for the proximal ureteral stone in the PCNL group and became stone-free after that. A second f-URS procedure due to lower pole stones was needed in 11 patients in group 2. Seven of them became stone-free after those procedures, resulting in an overall success rate of 76%. Finally, at 3rd months of follow-up, stone-free rates were found as 84.1% for PCNL and 76% for the s-URS group.

Complication rates among groups were similar. There were no perioperative complications in either group. In the postoperative period, mild complications such as colic pain and fever were observed in both groups. However, one patient in the s-URS group had a minimal subcapsular hematoma which was found to be resolved in the follow-up.

One patient in group 1 needed a blood transfusion, and double-j stenting due to the prolonged extravasation was performed in 3 PCNL cases. The creatinine level was not found to be increased in any patient.

Discussion

EAU guidelines recommended PCNL as the gold standard treatment of renal pelvic stones larger than 2 cm in diameter [1]. Since PCNL has high success rates, it also carries a significant risk of complications. The complication rates of PCNL procedures range between 0.04% to 10 % in the literature [2]. Those complications may range from mild fever or pain to even death [13].

The efficacy of PCNL in the treatment of large renal stones was reported in some studies. In one of them, Haggag et al. performed PCNL to treat 40 patients with renal pelvic stones larger than 2.5 cm and reported an SFR of 80% [14]. A more recent study including 30 patients with renal pelvic stones over 2 cm reported an SFR of 89%. Zengin et al. also evaluated the outcomes of PCNL in patients having 2-3 cm renal pelvic stones and reported a success rate of 95.5% [15]. Akman et al. also investigated the success rates of PCNL in patients who had renal stones 2-4 cm in diameter and reported an SFR of 91.2%, respectively [16]. Our success rate with PCNL at 3rd months of follow-up was similar to other renal pelvic stone series as 84.1%. Also, complication rates of PCNL were reported to be between 9-22% in those series, and our complication rate (15.9%) was consistent with the literature.

Technological improvements in the new generation of ureteroscopes such as small caliber URSs and digital optics and advances in laser lithotripsy have made the use of RIRS for renal stones more popular [4,5]. It has been widely accepted that RIRS procedures significantly decreased morbidity rates in the management of renal stones [17,18].

RIRS has good efficacy and less morbidity in the treatment of large renal stones. In many series, the overall success rates were reported to be between 77-93% after additional procedures for the treatment of renal stones larger than 2 cm [5,7,19]. More recently, Al-Busaidy et al. reported an 81% SFR with a mean average procedure number of 2.1 in 71 patients who had 2-4 cm renal stones [20]. In a recent systematic review, 10 RIRS studies were evaluated, and a SFR of 89.3% with an average of 1.6 procedures in 441 patients who had a mean stone size of 2,9 cm was determined [21].

Although RIRS series reported favorable outcomes, it must be emphasized that all those series were performed by f-URS which has some disadvantages including requirement for a second session, less durability, and high fiber breakage rates [5,6,22]. The requirement for additional sessions is the major disadvantage of RIRS, and it may not only increase the procedural costs but also expose the patients to additional anesthetic risks. It has also been noted that durability of f-URS is lower than s-URS and affected by number and complexity of procedures, the experience of the surgeon and sterilization methods [23]. Sung et al. reported that repair costs increased more with decreasing ureteroscope diameter and increasing instrument length for f-URS when compared to s-URS [6].

The same study also revealed the reasons for high fiber breakage rates for f-URS as the working channel damage from laser burn or instrument passage and extreme scope deflection with an indwelling instrument. Another disadvantage of f-URS is related to the use of ureteral access sheath (UAS). This auxiliary instrument is commonly preferred in RIRS cases up to 86% and used to facilitate the reentry into the ureter, decrease operative time and improve SFRs, particularly, in the treatment of large renal stones [24]. However, UAS cannot be placed into the ureter and may fail in one-fifth of the patients [25]. A prospective study investigated the ureteral wall injuries resulting from the insertion of a 14F UAS in 359 patients and revealed an 86.6% rate of low-grade injuries [26]. The rate of high-grade injuries were noted as 13.4% in the same study.

S-URS is a routine part of RIRS to dilate upper urinary tract and place a hydrophilic guidewire to the renal pelvis in many studies [16,27]. However, research on the use of s-URS to treat renal stones were limited, and s-URS is not accepted as a primary treatment modality. Success rates of s-URS at reaching renal pelvis were reported to be between 53-91% in some studies [9,10,28]. SFR and complications that were encountered in those series were presented in table-3.

Our s-URS group only consisted of patients whose stones were accessible with semirigid instruments and who had sufficient follow-up data. We determined an SFR of 60.8% after first s-URS procedures. This rate improved to 76% after additional f-URS sessions. However, it should be mentioned that SFRs, after first s-URS sessions, were inferior to f-URS series and 11 out of 18 men needed an eventual f-URS procedure for residual stones. A relatively acceptable SFR was achieved with the help of f-URS in our study. Using s-URS in the management of renal pelvic stones may offer some advantages such as shorter operation and hospitalization times when compared to f-URS and PCNL [9,10]. In our study, mean operation times was shorter in the s-URS group. However, this may be due to the definition of operative times. When compared to other s-URS studies, our sessions lasted longer, but this difference may be due to the large stone size of our study population. Our mean fluoroscopy times was significantly shorter in the s-URS group. It is well known that PCNL generally requires longer fluoroscopy times than RIRS and series with f-URS reported an average fluoroscopy time of 18 to 108 seconds. Since data about fluoroscopy times in s-URS studies were scarce, we cannot compare our data with those studies. However, our mean scopy time was found as 16.6 seconds which was lower than RIRS studies.

Mean hospital stay was also found to be lower in the s-URS group. Previous studies showed that the most important reason for this delay is the placement of a nephrostomy tube. Our mean hospital stays in our s-URS group is similar to other studies performed either with s-URS or f-URS.

Another advantage of s-URS is its cost-effectivity compared with f-URS and PCNL. It has been suggested that use of s-URS for the extraction of main stone mass may lead to lower procedural costs by decreasing the need for f-URS and protecting relatively fragile flexible instruments [7]. In addition, it is reported that s-URS is obviously more cost-effective than RIRS and PCNL, especially when the amount of painkillers used, hospital stay and operative times were taken into consideration [10]. It is also noted that cost of repair was two times higher for flexible ureteroscopes when compared with s-URS and using s-URS will minimize the repair costs of instruments [6]. The present study determined that f-URS is needed only in 11 of the 46 s-URS patients which means that s-URS decreased the need for f-URS. It can be concluded that therapeutic costs may be lowered by this way. However, we did not perform a cost analysis in this study.

The major disadvantage of s-URS was reported as its limited maneuvering ability during stone fragmentation and residual stones which mostly fall into lower calyces. Those stones cannot be reached s-URS and may lower the success rates. In addition to filling the lower calyces with autologous blood clots before RIRS, some maneuvers such as changing the position of the patient and filling/emptying the kidney pelvis can prevent the migration of stones and may facilitate the disintegration. However, if residual fragments migrate into lower calyces, it may be a better option to switch from s-URS to f-URS. Since we performed repositioning of the patient and filling/emptying the renal pelvis in our sURS group, 11 patients needed an additional f-URS procedure due to the migration of stones into lower calyces. Seven of those patients became stone-free and our final SFR improved to 76% with the aid of eventual f-URS sessions.

Our complication rates were comparable among groups. However, all those complications were mild (<clavien 2) in group 2. There were 7 patients with postoperative fever and colic pain. They were successfully treated with appropriate antibiotics and analgesics. The rate and type of the complications in our study were also consistent with other s-URS studies (9,10,28). We did not observe any septic complication in patients after those procedures.

This study determined that although s-URS is not superior to PCNL in the treatment of large pelvic stones, success rates became comparable with the aid of additional f-URS procedures in selected patients. Besides, s- URS provided shorter operation, fluoroscopy times and hospital stays when compared to PCNL. s-URS also decreased the primary need for f-URS use and by this means, may help to decrease the procedure and repair costs. It can be suggested that when renal pelvic access is easily achieved with s-URS, starting the procedure with that instrument seems reasonable for patients who have renal pelvic stones larger than 2 cm in diameter. If s-URS fails in the stone fragmentation due to its restricted maneuver ability, a combination with f-URS will be a more favorable option to provide stone-free status. In spite of those results, further prospective studies should be conducted to offer s-URS as an alternative to PCNL and f-URS.

Our study has several limitations. First, this is a retrospective study performed in a single tertiary care center. Second, we did not perform a cost analysis of groups. Relatively small patient cohort, lack of randomization and short follow-up period may be counted as the other limitations. An adequately powered and qualitatively designed randomized controlled trial with a comprehensive cost-analysis would be necessary to identify whether or not s-URS can hold up against the superior stone-free rates of PCNL and s-URS can be a valid alternative for PCNL or f-URS for this indication.

Conclusion

PCNL is the primary treatment modality for renal stones larger than 2 cm in size. Technological improvements made RIRS procedures more popular with comparable success and less morbid complication rates. Although s- URS cannot be offered as an alternative to PCNL and f-URS, it can be used for the fragmentation of renal pelvic stones with acceptable success and complication rates in selected cases. However, further prospective and randomized trials are needed to confirm these findings.

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Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

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Faruk Kucukdurmaz, Tayfun Sahinkanat, Caner Olmez, Mithat Temizer, Sefa Resim. Comparison Of Ureteroscopy And Percutaneous Nephrolithotomy For Renal Pelvic Stones Over 2 Cm. J Clin Anal Med. 2018;9(1):42-46

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What is the spectrum of histopathological diagnoses detected in hysterectomy specimens performed for benign conditions? Five years’ experience at the university hospital in Yozgat, a rural region of Turkey

Sevinç Şahin 1, Serdar Yanık 1, Taylan Onat 2, Mustafa Kara 2, Özlem Şimşek Tanın 2, Betül Aytekin 1, Ethem Serdar Yalvaç 2

1 Department of Pathology, 2 Department of Obstetrics and Gynecology, Bozok University School of Medicine, Yozgat, Turkey

DOI: 10.4328/JCAM.5358 Received: 13.09.2017 Accepted: 29.09.2017 Published Online: 29.09.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 38-41

Corresponding Author: Sevinc Sahin, Tıbbi Patoloji Anabilim Dalı, Bozok Üniversitesi Araştırma ve Uygulama Hastanesi, 66100, Yozgat, Türkiye. GSM: +905555576946 F.: +90 3542127010 E-Mail: sevcelik82@gmail.com

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Abstract

Aim: Hysterectomy is among the most common major surgical procedures performed in women. Approximately 450.000 hysterectomy procedures are per-formed each year in the United States for benign indications. The aim of this study was to evaluate hysterectomy procedures performed for benign conditions in terms of indications and histopathological results at a university hospital in a rural region of Turkey and correlate our results with the current data in the literature. Material and Method: A total of 41 total abdominal and vaginal hysterectomy materials performed for benign conditions were screened from the archive of Department of Pathology in Bozok University School of Medicine between January 2012 and December 2016. The hysterectomy indications and histopathological diagnosis of the hysterectomy specimens were re-evaluated, retrospectively. Demographical features were noted from the hospital records. PASW Statistics version 18.0 (SPSS Inc. Chicago. IL. USA) was used for statistical analysis. Results: The mean age of the patients was 45.68±4.72 (range: 36-60) years. The most common hysterectomy indication was uterine myoma which was observed in 31 cases (75.6%). The histopathological diagnosis of the hysterectomy materials were documented as follows in descending order; leiomyoma (n: 34, 82.9%), adenomyosis (n: 6, 14.6%), and endocervical polyp (n: 6, 14.6 %). The correlation between the histopathological diagnosis and patient’s age was evaluated; however, no statistically significant association was encountered (p>0.05). Discussion: We documented that the mean age of the patients underwent a hysterectomy in our study was lower than the literature, and leiomyoma frequency was generally higher than the literature. Further prospective studies comprising a greater number of patients might be crucial that would evaluate the etiology of these results.

Keywords: Hysterectomy; Benign Diseases; Histopathological Evaluation

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Introduction

Hysterectomy is among the most common major surgical procedures performed in women. Approximately 450.000 hysterectomy procedures are performed each year in the United States for benign indications [1]. The most frequent indications for hysterectomy are abnormal uterine bleeding resistant to medical treatment, myoma uteri and endometrial hyperplasia [2]. Other clinical indications are adenomyosis and uterine prolapse. The most common histopathological diagnoses reported for hysterectomy specimens are leiomyoma, adenomyosis and endometrial hyperplasia [2].

The aim of this study to evaluate hysterectomy procedures performed for benign conditions to detect our indications and histopathological results at a university hospital in a rural region of Turkey, and correlate our results with the current data in the literature.

Materials and Method

Case selection

A total of 41 patients that were given informed consent underwent total abdominal hysterectomy or vaginal hysterectomy for benign conditions consecutively between January 2012 and December 2016 at Bozok University School of Medicine were included in the study. The cases operated for malignant or premalignant diseases were excluded. The demographical features (age and gender) of the patients, hysterectomy indications, and histopathological diagnoses were screened from the hospital records and archive of Pathology Department.

Statistical Analysis

PASW Statistics version 18.0 (SPSS Inc. Chicago. IL. USA) was used for statistical analysis. The demographic variables were detected using descriptive statistics. Data were expressed as mean±standard deviation (SD), and percent (%) where appropriate. The Chi-square test was used to correlate histopathological diagnosis and patient’s age. P<0.05 was considered as statistically significant.

Results

The age of the patients ranged from 36 to 60 (mean: 45.68±4.72) years. Among 41 cases, 40 (97.5%) were operated by total abdominal hysterectomy procedure, 1 (12.5%) was operated by vaginal hysterectomy procedure.

The most common hysterectomy indication was uterine myoma which was observed in 31 cases (75.6%). The other indications were as follows in a descending order: abnormal uterine bleeding resistant to medical treatment (n:6, 14.7%), uterine prolapse (n:2, 4.9%), uterine atony (n:1, 2.4%), and endometrial hyperplasia (n:1, 2.4%) (Table 1).

The histopathological diagnoses of the hysterectomy materials were documented as follows in a descending order; leiomyoma (n:34, 82.9%) (mean age: 46.00±3.90, range:36-52 y), adenomyosis (n:6, 14.6%) (mean age:45.14±4.44, range:39-51 y), endocervical polyp (n:6, 14.6 %) (mean age:49.00±2.75, range:46-52 y), chronic endometritis (n:4, 9.8%) (mean:46.00±2.16, range:44-49 y), simple endometrial hyperplasia (n:2, 4.9%) (mean age:43.50±0.70, range:44-45 y), endometrial polyp (n:2, 4.9%) (mean age:44.50±0.70, range:43-44 y), and smooth muscle tumor with undetermined significance (STUMP) (n:1, 2.4%) (44 y) (Table 2). Among those cases diagnosed as leiomyoma, 1 (2.4%) (49 y) case was subtyped as cellular leiomyoma, 1 (2.4%) (43 y) case was subtyped as mitotic active leiomyoma (Table 2).

Concurrent different lesions were found in 17 (41.4%) cases. Concurrent leiomyoma and endocervical polyp was detected in 8 (19.5%) (mean age:49.00±2.75, range:46-52 y) cases; leiomyoma and adenomyosis was detected in 4 (9.8%) (mean age:46.50±4.20, range:41-51 y) cases; leiomyoma and endometritis was detected in 4 (9.8%) (mean: 45.75±2.50, range:43-49 y) cases; simple endometrial hyperplasia, endometrial polyp and leiomyoma was detected in 1 (2.4%) (45 y) case; simple endometrial hyperplasia and leiomyoma was detected in 1 (2.4%) (43 y) case (Table 3).

Leiomyoma, adenomyosis, chronic endometritis, simple endometrial hyperplasia, and endometrial polyp were mostly detected in the patients younger than 50 years (Table 4). The correlation between the histopathological diagnosis and patient’s age was evaluated; however, no statistically significant association was encountered (p>0.05) (Table 4).

Discussion

Hysterectomy is the most common gynecologic surgical procedure performed after cesarean section. It is applied for the treatment of leiomyoma, dysfunctional uterine bleeding, pelvic inflammatory disease, adenomyosis, endometriosis, gynecological cancers, uterovaginal prolapse, chronic pelvic pain, obstetric complications, and gestational trophoblastic diseases [3-6].

The mean age of the patients who underwent hysterectomy varies among different studies in the literature. İşgüder et al. [3] have reported the mean age as 50.48±7.50 (range: 38-74), İsaoğlu et al. [2] reported as 46±5.78 (range: 36-68), Turgut et al. [7] reported as 48.18±5.87 (range: 39-67), Dinçgez et al. [8] reported as 50.54±9.5 years. The mean age of the patients in our study is 45.68±4.72 (range: 36-60) and significantly lower than that of similar studies [3,7,8].

The most frequent hysterectomy indications in the study of İşgüder et al. were leiomyoma (45.3%) [3]. Dysfunctional uterine bleeding, endometrial hyperplasia, uterine prolapse, chronic pelvic pain, and adenomyosis were the other indications respectively as 29.49%, 12.9%, 10%, 1.2%, and 1.2% [3]. İsaoğlu et al. reported the most common indication for hysterectomy as abnormal uterine bleeding (33.72%). Myoma (28.29%) and endometrial hyperplasia (25.96%) were the other indications in a descending order of frequency [2]. Turgut et al. documented similar frequency of hysterectomy indications as İsaoğlu et al. [2] as follows: abnormal uterine bleeding (75%), myoma (12.50%) and endometrial hyperplasia (6.25%), respectively [7]. Dinçgez et al. reported leiomyoma (32.77%), adnexal masses (14.65%) and pelvic organ prolapse (13.49%) in a decreasing order of frequency for hysterectomy indications [8]. In our study, the most common indication was myoma (75.6%), which is similar to the studies of İsgüder et al. and Dinçgez et al. It is also striking that frequency of myoma was higher than the other studies [2,3,7,8]. The other indications were as follows: abnormal uterine bleeding, uterine prolapse, uterine atony, and endometrial hyperplasia (14.7%, 4.9%, 2.4%, and 2.4%, respectively) in the present study.

Histopathological evaluation of hysterectomy materials revealed leiomyoma (51.2%), adenomyosis (20.5%), endometrial hyperplasia (18.3%), endometrial polyp (10%), and atrophic endometrium (4.1%) in the study of İşgüder et al. [3]. Ojeda et al. showed that 44.0% of the hysterectomy cases were leiomyoma, 22.3% of them were endometrial hyperplasia, 12.23% were malign disorders, and 6.44% were endometriosis [9]. Atılgan et al. evaluated 361 hysterectomy specimens and demonstrated uterine myoma of 40.16%, endometrial hyperplasia of 38.22%, adenomyosis of 25.48% and endometrial polyp of 8.86% [10]. Isaoglu et al. showed 32.17% cases of leiomyoma, 30.23% cases of adenomyosis, 29.84% cases of endometrial hyperplasia and 5.04% cases of endometrial polyp [2]. Turgut et al. documented the most common lesion was leiomyoma (46.87%) followed by adenomyosis (12.50%), endometrial hyperplasia (9.38%), endometrial polyp (3.13%) and combined pathologies (21.87%) [7].

Uterine leiomyoma is the most common benign tumor of the female pelvis and uterus and constitutes the most common soft-tissue tumor. In postmortem examinations, it was detected in 50% of women. It is the most common lesion detected in hysterectomy specimens in many studies [2,3,7,9,10]. The leiomyoma incidence varies from 32.17% to 77% in the literature [2,3,7,9,10]. In our study that leiomyoma incidence was 82.9% which is more than the literature.

Adenomyosis is characterized by the presence of endometrial glands and stroma within the myometrium. Patients are typically pre- or peri-menopausal women who present with abnormal bleeding [11]. In adenomyosis, the uterus grows diffusely and is often accompanied by uterine leiomyomas [12]. Adenomyosis is the second most common lesion in our study and is the second most common lesion, as in the studies of Isaoğlu et al. [2], Turgut et al. [7] and İşgüder et al. [3] It is the third most common lesion as in the studies of Ojeda et al. [9] and Atılgan et al. [10].

In summary, we analyzed the spectrum of the lesions in hysterectomy specimens in our archives. We documented that the mean age of the patients underwent a hysterectomy in our study was lower than the literature, and leiomyoma frequency was generally higher than the literature. Further prospective studies comprising a greater number of patients might be crucial that would evaluate the etiology of these results.

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References

1. Mehta A, Xu T, Hutfless S, Makary MA, Sinno AK, Tanner EJ, et al. Surgeon and hospital disparities associated with benign hysterectomy approach and perioperative complications. Am J Obstet Gynecol. 2016; 216(5): 497.e1-e10.

2. Isaoğlu U, Yılmaz Mİ, Delibaş İB, Gözükara İ, Bilici E, Uluğ P, et al. The evaluation of histopathologic diagnosis in specimens of hysterectomy. Abant Med J. 2013; 2(2):91-4.

3. İşgüder ÇK, Doğru HY, Özsoy AZ, Çakmak B, Delibaş İB, Arıcı A, et al. The evaluation of histopathological diagnosis ın hysterectomy materials. J Contemp Med. 2016; 6(2): 87-91.

4. Pokras R. Hysterectomy, past, present, and future. Stat Bull Metrop Insur Co. 1989; 70(4): 12-21.

5. Benrubi GI. History of hysterectomy. J Fla Med Assoc. 1988; 75(8): 533-8.

6. Davies A, Magos A. Indications, and alternatives to hysterectomy. Bailliere’s Clin Obstet and Gynaecol. 1997; 11(1): 61-75.

7. Turgut O, Yanık S, Ay AA, Gencay I, Nergiz S, Ay A, et al. The evaluation of preoperative and histopathologic diagnosis in specimens of hysterectomy performed for benign conditions. Journal of Surgery. 2014; 2(1): 11-3.

8. Dinçgez B, Coşkun Eİ, Ayanoğlu YT. Evaluation of hysterectomy cases in our clinics. Şişli Etfal Hastanesi Tıp Bülteni. 2011; 45(2): 35-8.

9. Ojeda VJ. The pathology of hysterectomy specimens. Z Med J. 1979; 89(631): 169-71.

10. Atılgan R, Boztosun A, Ozercan MR. Histerektomi materyallerinde histopatolojik tanıların insidansı. Fırat Tıp Dergisi. 2012; 17(1): 19-29.

11. Rizvi G, Pandey H, Pant H, Chufal SS, Pant P. Histopathological correlation of adenomyosis and leiomyoma in hysterectomy specimens as the cause of abnormal uterine bleeding in women in different age groups in the Kumaon region: A retrospective study. J Midlife Health. 2013; 4(1): 27–30.

12. Arif A, Jamal S, Mubarik A, Zubair A, Ghori UK. Study of adenomyosis in different decades of life: An experience at army medical college, Rawalpindi-Pakistan. Pak J Pathol. 2007; 18(3): 75-8.

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Sevinç Şahin, Serdar Yanık, Taylan Onat, Mustafa Kara, Özlem Şimşek Tanın, Betül Aytekin, Ethem Serdar Yalvaç. What is the spectrum of histopathological diagnoses detected in hysterectomy specimens performed for benign conditions? Five years’ experience at the university hospital in Yozgat, a rural region of Turkey. J Clin Anal Med. 2018;9(1):38-41

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The use of negative pressure therapy in the treatment of defects resulting from failed reconstruction in the neck region

Erkan Orhan 1, Engin Başer 2

1 Department of Plastic Surgery, Namik Kemal University, Tekirdağ, 2 Department of Otorhinolaryngology, Balıkesir Bandırma Public Hospital, Balıkesir, Turkey

DOI: 10.4328/JCAM.5314 Received: 21.08.2017 Accepted: 10.10.2017 Published Online:10.10.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 34-7

Corresponding Author: Erkan Orhan, Reşat Nuri Sk 71/31 Y.Ayrancı Çankaya, Ankara, 06510, Türkiye. GSM: +905325004192 F.: +90 2822509928 E-Mail: eorhan@yahoo.com

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Aim: Reconstruction of defects after tumor excision in neck region is very difficult because fistula formation between oral cavity/pharyngeal space and defects is frequently encountered. Salivary swelling through the fistula disrupts wound healing. This study aims to show the effectiveness of negative pressure treat-ment (NPT) in the treatment of neck defect with fistula formation. Material and Method: Patients who had neck defects with orocutaneous or pharyngocutane-ous fistule and treated with NPT between January 2012 and January 2015 were included in the study. Result: 9 patient who had neck defects with orocutaneous or pharyngocutaneous fistule treated with NPT between January 2012 and January 2015. With the application of an average of 6.11 sessions NPT treatment, the salivary secretion terminated and the formation of granulation tissue was provided. With NPT, secondary healing was observed in 2 patients, and the defect was reconstructed with a local flap in the other 7 patients. Discussion: It is recommended that NPT can be used to repair the defects with orocutaneous or pharyngocutaneous fistules in neck region

Keywords: Neck; Fistula; Negative Pressure Therapy

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Introduction

Reconstruction of defects after tumor excision in the head and neck region is very difficult due to the irregularity of the region’s surface, inadequacy of local tissues, and frequent infection depending on proximity to the mouth flora. The most commonly used method for reconstruction of defects in the head and neck region is flap reconstruction. In the treatment of cancers in the head and neck region, preoperative or postoperative radiotherapy is mostly used in addition to surgical excision of the tumor. Radiotherapy increases the incidence of partial or total flap loss and causes the failure of reconstruction since it disrupts the skin circulation in this area [1,2].After radiotherapy, a fistula connecting the oral cavity and the pharyngeal space is frequently encountered in defects in the neck region. The secretions in the mouth and pharynx accumulate in the dead space created by these fistulas after tumor excision and neck dissection, and this situation increases mortality and morbidity by causing complications such as deep neck infection, rupture of large vessels, and flap loss [1,2].

In 2008, Andwers et al. used negative pressure therapy (NPT) for the first time in the repair of defects in the neck region and reported to achieve successful results [3,4]. NPT is an active wound closure method used in the treatment of acute, subacute, chronic and infected wounds. Thanks to NPT, large defects can be closed with a simpler surgery method, and small defects can be closed without surgery [5]. Many studies have shown that NPT is effective in the various types of wounds (e.g. trauma, burn, oncologic resection, radiation, and vascular insufficiency) in different locations such as the abdomen, perineum, trunk, and limbs [2].

This study is aimed to share our experience with the use of NPT in the treatment of defects accompanied by orocutaneous and pharyngocutaneous fistulas, which developed following failed reconstruction after tumor excision in the tissues of the neck where radiotherapy was applied.

Material and Method

After institutional review board approval, patients who underwent tumor excision and neck dissection and were treated with radiotherapy between January 2012 and January 2015 were examined retrospectively. Patients who had orocutaneous and pharyngocutaneous fistulas and defects after failed reconstruction in the neck region and who underwent NPT for the treatment of these defects were included in the study. The age, gender, primary disease, duration of NPT and reconstruction method of the patients were determined.

All patients underwent NPT using the vacuum assisted closure (VAC) device (Kinetic Concepts, Inc., San Antonio, Texas, USA). After the polyurethane sponge was cut according to the wound size, it was placed on the wound surface so that the entire surface would be filled but not over the wound. Then, it was sealed with an adhesive sheet to create an airtight environment. A hose was attached to a small hole opened on the sponge, and the other end of the hose was connected to the collection container in the device. The pressure was set at 125 mmHg. It was applied in a continuous mode during the first 24 hours and then in an intermittent mode (5:1). The VAC sponge was changed every three days.

Result

There were 9 male patients who had orocutaneous and pharyngocutaneous fistulas and defects after failed reconstruction in the neck region and who underwent NPT for the treatment of these defects between January 2012 and January 2015. The mean age of the patients was calculated as 61.33 years. Five patients were operated due to laryngeal carcinoma, and 4 patients were operated due to the cancer of the mouth floor in the Department of Otolaryngology. Each patient underwent modified radical neck dissection. All patients underwent radiotherapy before surgery. In the postoperative period, a pharyngocutaneous fistula developed in patients operated due to larynx carcinoma, and orocutaneous fistula developed in patients operated due to the floor of the mouth cancer. No large vessels were seen on the floor of the defect in any of the patients.

The wounds of all patients were debrided under general anesthesia, and orocutaneous and pharyngocutaneous fistulas were sutured so that mucosal side was airtight and waterproof. Then, NPT was started. NPT was applied for an average of 6.11 sessions until the dead spaces within the wound became obliterated, the salivary secretion terminated, and the formation of granulation tissue was provided. Secondary healing with NPT was observed in 2 patients, and the defect was reconstructed with a local flap in the other 7 patients.

Discussion

In NPT, the negative pressure is applied equally to the entire wound surface with the help of a sponge made of polyurethane foam. With the negative pressure applied, excess exudate and edema are absorbed, and turgor pressure is reduced. Thus, the vessels around the wound are dilated, and blood flow and oxygenation to the wound area increase [4].

The negative pressure also reduces the bacterial load on the wound and creates an equal amount of mechanical force against the tissues around the wound [5,6]. Mechanical force induces angiogenesis and tissue growth in the tissues and allows the surrounding tissues to move towards the center of the defect, and eventually, the wound sizes are getting smaller [7]. It was shown that NPT increased the formation of granulation tissue 4 times compared to the moist wound dressing and increased the healing rate by shortening the wound healing process [8,9].

In defects occurring after tumor resection in the neck region, orocutaneous and pharyngocutaneous fistulas can develop due to the proximity of the defect to the oral cavity and the pharyngeal wall [1,2]. Orocutaneous and pharyngocutaneous fistulas mainly develop due to the poor circulation in the tissues in the region after radiotherapy and the improper suture techniques [1]. Saliva flows into the defects through orocutaneous and pharyngocutaneous fistulas. Saliva that accumulates here also leads to infection or soft tissue necrosis, resulting in the failure of reconstruction. Thus, failed reconstruction causes defects to occur again.

In the treatment of orocutaneous and pharyngocutaneous fistulas, it is first necessary to suture the mucosa as airtight and waterproof. The system will not work if there is air leakage in the environment during NPT. Therefore, the fact that the system actively works shows that it is sutured so that mucosal side is airtight and waterproof. This situation further accelerates wound healing by ensuring that the salivary secretion does not occur [1,3].

125 mmHg negative pressure was used in our study. When the effects of different amounts of the negative pressure on the wound were examined, it was determined that the optimal negative pressure was 125 mmHg [10]. High negative pressure disrupts wound healing by creating ischemia. Conversely, low negative pressure does not adequately increase microvascular blood flow. The balance between high and low negative pressure can be achieved by assessing the patient’s microvascular blood flow, the patient’s ability to tolerate it, and detection of lymphatic drainage. In our study, 125 mmHg negative pressure applied to the neck region was easily tolerated by all patients and accelerated wound healing. Since NPT is portable, the patients were not required to adhere to the bed during our study. The fact that wound dressing was changed every 3 days significantly reduced the workload of the healthcare team. Previous studies have shown that the cost of NPT was lower than that of conventional therapy [1,11].

Some complications such as adhesion of sponges to wound region, pain, and damage of vessels that are exposed can be seen after NPT, but these adverse complications were not seen in any of the patients in our study [1].

In our study, orocutaneous and pharyngocutaneous fistulas were obliterated with NPT in all patients, and wound healing was shown to be faster. All defects could be reconstructed as secondary or by local flaps.

Conclusion

It was observed that use of NPT accelerated wound healing and healing of orocutaneous fistula in the head and neck region which is a difficult reconstruction site. For these reasons, it is recommended to be used in the repair of defects in the head and neck region.

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Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

References

1.Yang YH, Jeng SF, Hsieh CH, Feng GM, Chen CC. Vacuum-assisted closure for complicated wounds in head and neck region after reconstruction. J Plast Reconstr Aesthet Surg. 2013;66(8):e209-16.

2.Satteson ES, Crantford JC, Wood J, David LR. Outcomes of Vacuum-Assisted Therapy in the Treatment of Head and Neck Wounds. J Craniofac Surg. 2015;26(7):599-602.

3.Andrews BT, Smith RB, Hoffman HT, Funk GF. Orocutaneous and pharyngocutaneous fistula closure using a vacuum-assisted closure system. Ann Otol Rhinol Laryngol. 2008;117(4):298-302.

4.Joseph E, Hamori CA, Bergman S, Roaf E, Swann NF, Anastasi GW. A prospective randomized trial of vacuum-assisted closure versus standard therapy of chronic nonhealing wounds. Wounds. 2000;12(3):60–7.

5.Argenta L, Morykwas M. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997;38(6):563–76.

6.Narayanan K, Futrell JW, Bentz M, Hurwitz D. Comparative clinical study of the sure-closure device with conventional wound closure techniques. Ann Plast Surg. 1995;35(5):485–91.

7.DeFranzo AJ, Argenta LC, Marks MW, Molnar JA, David LR, Webb LX, et al. The use of vacuum-assisted closure therapy for the treatment of lower-extremity wounds with exposed bone. Plast Reconstr Surg. 2001;108(5):1184–91.

8.Korkmaz F. Basınç Yarası Bakımında Topikal Negatif Basınç Terapisi. Hacettepe Hemşirelik Dergisi. 2011(1);93-102.

9.McCallon SK, Knight CA, Valiulus JP, Cunningham MW, McCulloch JM, Farinas LP. Vacuum-assisted closure versus saline-moistened gauze in the healing of postoperative diabetic foot wounds. Ostomy Wound Manage. 2000;46(8):28-32.

10.Borgquist O, Ingemansson R, Malmsjö M. Wound edge microvascular blood flow during negative-pressure wound therapy: examining the effects of pressures from -10 to -175 mmHg. Plast Reconstr Surg. 2010;125(5):502-9.

11. Fries CA, Jeffery SL, Kay AR. Topical negative pressure and military wounds review of the evidence. Injury. 2011; 42(5): 436-40.

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Erkan Orhan, Engin Baser. The use of negative pressure therapy in the treatment of defects resulting from failed reconstructi. J Clin Anal Med. 2018;9(1):34-37

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Small intestinal perforations due to acquired internal herniation

Volkan Oter 1, Mehmet Tolga Kafadar 2, Serdar Oter 3

1 Department of Gastroenterological Surgery, School of Medicine, Sakarya Unıversity, Sakarya, 2 Department of General Surgery, Health Sciences University, Mehmet Akif İnan Training and Research Hospital, Şanlıurfa, 3 Department of Gastroenterological Surgery, School of Medicine, Mersin Unıversity, Mersin, Turkey

DOI: 10.4328/JCAM.5264 Received: 02.08.2017 Accepted: 18.09.2017 Published Online: 18.09.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 31-3

Corresponding Author: Volkan Öter, Department of Gastroenterological Surgery, School of Medicine, Sakarya Unıversity, Kemalpasa, Sakarya, Turkey. GSM: +905053366333 F.: +90 2642955032 E-Mail: otervolkan@gmail.com

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Aim: An internal hernia is a very rare cause of acute small bowel obstruction and perforation which may be difficult to diagnose. We aimed to provide a retro-spective study for management and evaluated patients who underwent surgery for perforation due to intestinal internal herniation in our department. Material and Method: From January 2012 to April 2017, seven patients underwent surgery for a perforation due to intestinal internal herniation at our clinic. We retro-spectively reviewed the patients’ records, imaging modalities, and operative findings. Results: There were two women and five men with a mean age of 52.50 ± 11.22 years. All patients were admitted to our emergency surgery unit with the complaints of acute abdominal pain, distension, and fever. All patients were urgently operated. The mean hospital stay was 5.50 ± 1.37 days. In the postoperative period, two patients had wound infection, and postoperative mortality was not observed. Discussion: Perforation due to an internal hernia occur because of the delayed diagnosis of the internal hernia. Unfortunately, they have bad outcomes. They usually rapidly progress to bowel ischemia once strangulated and have no definitive predictors. At surgery, complete closure of the potential defects that may predispose to an internal hernia is essential for prevention. Especially in patients who had previous abdominal surgery, internal hernia should be kept in mind to prevent delay in diagnosis.

Keywords: Acute Abdomen; Acquired Internal Herniation; Surgery

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Introduction

An internal hernia (IH) is a very rare cause of acute small bowel obstruction and perforation which may be difficult to diagnose. It occurs spontaneously or as a complication of abdominal surgery. In the acute setting, symptoms occur when the bowel trapped in one of the defects leads to closed-loop obstruction with subsequent significant morbidity and mortality. Spontaneous perforation is a challenge in surgery because of it’s difficult diagnosis. The mortality rate is reportedly higher in acquired IHs, but the majority of these reports involved a limited number of cases [1,2]. Therefore, we aimed to provide a retrospective study for management and evaluated seven patients who underwent surgery for perforation due to intestinal internal herniation in our department.

Material and Method

From January 2012 to April 2017, seven patients underwent surgery for perforation due to intestinal internal herniation at Health Sciences University Şanlıurfa Mehmet Akif İnan Training and Research Hospital. We reviewed the patients’ records, imaging modalities, and operative findings. All patients underwent surgery; with regard to operative findings and patient history.

Statistical Analysis

Data were evaluated with the statistical SPSS package, version 13.0 (Chicago, IL). Data were expressed as mean _ standard deviation (SD) or median (range).

Results

Five men and two women with a mean age 52.50 ± 11.22 years were evaluated. Demographic and clinical features are shown in Table 1. All patients were admitted to our emergency surgery unit with the complaints of acute abdominal pain, distension, and fever. Physical examination showed signs of acute abdomen and intraabdominal sepsis. The interval between the development of acute symptoms and hospitalization ranged from several hours to 2 days (mean time: 26.67 ± 10.25 hours). All patients had at least one abdominal plain X-ray done, which showed a bowel obstruction and free air in the peritoneal cavity in all patients (Fig. 1). Four patients underwent abdominal computed tomography (CT) scanning with intravenous contrast material. On CT; dilated intestines, intra-abdominal fluid and free air in the peritoneal cavity were detected (Fig. 2). Following correction of hemodynamic instability and electrolyte imbalance, the patients were taken to the operation room. Exploratory laparotomy was performed. In surgery, intestinal perforations were observed proximally to the internal herniation of the small bowel in all patients. On further exploration, internal herniation of the proximal ileal loop resulting in the necrosis of the involved small bowel segments with perforation was detected in four patients. Segmental intestinal resection including all diseased segments of the ileum, terminal ileostomy, and distal mucous fistula was performed in these patients. Internal herniation of the proximal ileal loop resulting in proximal intestinal perforation without necrosis was detected in the other three patients. The release of a herniated segment and primary suture of the perforation area were successfully completed. The abdomen was washed with 2000 cc warm saline then aspirated in all of the patients. After drains were placed in the abdomen, operations were terminated. Type of the internal herniations are shown in Table 1. The mean hospital stay was 6.50 ± 2.37 days (range, 5-9 days). In the postoperative period, two patients had wound infection, and postoperative mortality was not observed.

Discussion

Internal hernias only constitute for 1.9–3% of cases of small bowel obstruction [3]. IHs are often diagnosed very late; especially in most cases diagnosis is made at the time of laparotomy, usually following the clinical picture and plain radiographic findings of bowel obstruction. Unfortunately, IHs have a rapid progression to bowel ischemia and/or bowel perforation which is a life-threatening emergency. To date, most of these reports about IHs are case reports or studies with a limited number of patients, probably because of the low incidence of 0.2–0.9% [4-6].

Despite the limited number of cases, this report represents one of the largest series about spontaneous perforation due to acquired intestinal internal herniations. In some studies, mortality following strangulated small bowel obstruction is 3–44%, no mortality and morbidity study was found about spontaneous perforation [7,8]. In the medical histories of our patients, all patients reported that they were admitted to the emergency department due to crampy abdominal pain at least once, but they were treated medically and discharged after the relief of the symptoms. Therefore, the diagnosis of IH is essentially based on a high index of suspicion. There are no laboratory findings specific to this disease [2].

Radiologically; CT scanning is one of the best diagnostic methods, which can diagnose complete or partial obstruction and closed-loop obstruction much better than a plain abdominal X-ray. Intramural abnormalities such as mural thickening and pneumatosis intestinalis are also well verified by CT scanning [9].

In older literature, congenital internal hernias were the most frequent types of all IHs, but recent studies report the increase of the acquired types [10,11]. The surgical treatment results for congenital types were also much better than the results for acquired types [12-15]. Delayed laparotomy time (>3 days after the onset of the symptoms) and the presence of a comorbidity were related to high morbidity [16]. In acquired IHs, transmesenteric hernias are increasing in incidence, and also, they are more likely to develop volvulus and strangulation or ischemia and perforation [17-19]. The second type of IHs that occurs when the bowel prolapses through a defect in the small bowel mesentery was the most common type in this study with five patients. Defects in the small bowel mesentery should be surgically completely closed. Because incomplete closure or breakdown of the surgical sutures may occur, leading to a potential site for IHs [20].

According to our study, the most important factors affecting the prognosis of the patient is the early diagnosis and proper management, before the development of irreversible damage to the intestinal wall. Urgent surgical intervention to prevent strangulation, which is responsible for high mortality, is essential.

Conclusion

Spontaneous perforation due to IH occurs because of the delayed diagnosis of IH. Unfortunately, they have bad outcomes. They usually rapidly progress to bowel ischemia once strangulated and have no definitive predictors. At surgery, complete closure of the potential defects that may predispose to IH is essential for prevention. Because of the difficulty with diagnosis and the potentially disastrous complication of gangrenous and even perforated bowel, symptomatic patients with signs of small bowel obstructions on a plain abdominal film should undergo a rapid evaluation for proper immediate therapy. Especially in patients who had previous abdominal surgery, internal hernia should be kept in mind to prevent delay in diagnosis.

All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Animal and human rights statement

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

References

1. Renvall S, Niiinikoski J. Internal hernia after gastric operations. Eur J Surg. 1999;157(10):575-7.

2. Fan HP, Yang AD, Chang JG, Juan CW, Wu HP. Clinical spectrum of internal hernia: a surgical emergency. Surg Today. 2008;38(10):899-904.

3. Ghosheh B, Salameh JR. Laparoscopic approach to acute small bowel obstruction: review of 101 cases. Surg Endosc. 2007; 21(11): 1945-9.

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Investigation of malnutrition in hospitalized children: a point prevalence study from Kayseri

Pembe Soylu Ustkoyuncu 1, Ayşe Betül Ergül 2, Yasemin Altuner Torun 2

1 Pediatric Nutrition and Metabolism Clinic, 2 Pediatrics Clinic, Health Sciences University, Kayseri Training and Research Hospital, Kayseri, Turkey

DOI: 10.4328/JCAM.5259 Received: 31.07.2017 Accepted: 26.08.2017 Published Online: 26.08.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 27-30

Corresponding Author: Pembe Soylu Ustkoyuncu, Pediatric Nutrition and Metabolism Clinic, Health Sciences University, Kayseri Training and Research Hospital, 38170, Kocasinan, Kayseri, Turkey. T.: +90 3523512240/7115 F.: +90 3523512244 E-Mail: drpembesoylu@erciyes.edu.tr

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Aim: The aim of this study is to evaluate the nutritional status of children who stayed in our hospital. Malnutrition is a clinic and pathological condition resulting from inappropriate intake of one or more nutrients to disrupt the body’s physiological and metabolic balance. It is one of the most common health problems in developing countries and affects mostly children between the ages of six months and five years. Material and Method: A one-day cross-sectional survey was completed in all Pediatric Clinics of Emel Mehmet Tarman Children Health and Illness Hospital on May 16, 2017. Nutritional status of patients were evaluated. Results: Fifty-nine (49.1%) of 120 patients were female, 61/120 (50.9%) patients were male, and the ages of patients range between 1 month and 18 years and 4 months. Fifty-eight (48.3%) cases were between 1-24 months, 22 (18.3%) cases were between 2-6 years, 16 (13.3%) cases were between 6-10 years and 24 (20%) were between 10-18 years and four months. Twenty-five (20,8%) of 120 patients had malnutrition according to the Waterlow classification. Acute malnutrition was detected in 12 (48%) of 25 malnourished patients. Seven of the 12 patients (58.8%) had mild, 4 had moderate (33,3%), and 1 (8,3%) had severe acute malnutrition. Four (16%) of 25 patients had chronic malnutrition, 3/4 (75%) had severe, and 1/4 (25%) had moderate chronic malnutrition. Nine (36%) of 25 patients had chronic malnutrition with acute decompensation. Discussion: High rates of malnutrition were detected in hospitalized patients; therefore nutritional status should be carefully assessed at the moment of hospitalization to reduce the mortality and morbidity rate, and patients should be given nutritional support.

Keywords: Children; Malnutrition; Point Prevalence

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Introduction

Malnutrition is a clinic and pathological condition resulting from inappropriate intake of one or more nutrients to disrupt the body’s physiological and metabolic balance. It is one of the most common health problems in developing countries and affects mostly children between the ages of six months and five years.

Child malnutrition was associated with 54% of child deaths in developing countries. Unfortunately, more than 50% of children with severe malnutrition dies [1,2].

There are many factors that affect nutritional status in children. These factors may be low birth weight, premature weaning, inadequate health conditions, unfavorable socioeconomic and environmental conditions. The distribution and grade of malnutrition vary according to many factors such as the level of education, the condition of sanitation, climate and seasonal characteristics, cultural and religious habits, breastfeeding rates, the prevalence of infectious diseases, and the rate of application of community nutritional programs [3-5].

Nutritional status should first be assessed by history, physical examination, and laboratory examinations [6]. The characteristics of the diet, presence of low birth weight, duration of breastfeeding, the period of weaning, types of preparation and administration of supplementary foods, presence of chronic diseases and drugs, socioeconomic and cultural status of the family should be questioned in detail [7].

Physical examination should be done in detail, and anthropometric parameters should be measured. Growth curves of Neyzi et al. are frequently used in our country [8]. The growth of a child is best assessed by continuous anthropometric measurements, but information on the nutritional status can be obtained by comparing the values obtained with a single measurement to standards and using some calculations.

Material and Method

A one-day cross-sectional survey was completed in all pediatric clinics of Emel Mehmet Tarman Children Health and Illness Hospital, Kayseri Training and Research Hospital, Health Sciences University from Kayseri on May 16, 2017.

The age, sex, diagnosis, body weight, height, physical examination findings, characteristics of the diet, birth weight, duration of breastfeeding, period of weaning, types of preparation and administration of supplementary foods, presence of chronic diseases and drugs, socioeconomic and cultural status of the family and monthly family income were recorded.

The Waterlow classification was used for assessment of malnutrition. According to this classification; cases were accepted as acute malnutrition with a weight for height less than 90% and height for age over 95%. Cases were accepted as chronic malnutrition with a weight for height 90-110% and height for age less than 95%. Cases were accepted as acute decompensation of chronic malnutrition with a weight for height less than 90% and height for age less than 95%. Weight for height between 90% and 80% describe mild, between 80% and 70% describe moderate, and below 70% describe severe acute malnutrition [9]. The study was approved by the local Ethical Committee of the Erciyes University Medical Faculty.

Results

Fifty-nine (49.1%) of 120 patients were female, 61/120 (50.9%) patients were male, and the ages of patients range between 1 month and 18 years and 4 months.

Fifty-eight (48.3%) cases were between 1-24 months, 22 (18.3%) cases were between 2-6 years, 16 (13.3%) cases were between 6-10 years and 24 (20%) were between 10-18 years and four months. Twenty-five (20,8%) of 120 patients had malnutrition according to the Waterlow classification. Forty-eight percentage of malnourished patients were between 1-24 months. Thirteen of 25 malnourished patients were female, and 12 patients were male. Their ages ranged from 30 days to 18 years and 4 months.

Acute malnutrition was detected in 12 (48%) of 25 malnourished patients. Seven of the 12 patients (58.8%) had mild, 4 had moderate (33,3%), and 1 (8,3%) had severe malnutrition.

Four (16%) of 25 patients had chronic malnutrition, 3/4 (75%) had severe, and 1/4 (25%) had moderate chronic malnutrition. Nine (36%) of 25 patients had chronic malnutrition with acute decompensation. Twelve patients (48%) with malnutrition were following in intensive care unit.

Twenty-eight percent of the cases with malnutrition had a neurological disease, 20 % had a syndrome, 20 % had an infectious disease, 8 % had malignancy, 4 % had non-malignant hematological disorders, 12 % had an endocrine disease, 8 % inborn error of metabolism. Five patients had sepsis, and septic shock in addition to primary disease and one patient had nosocomial pneumonia. Three (60 %) of 5 patients with a syndrome had cleft palate and one had Down syndrome. According to socioeconomic status; monthly family income was low in 80% of malnourished children. Characteristics of the patients with malnutrition are shown in Table 1.

Discussion

Children who are growing and developing organisms have a higher nutritional requirement than adults. Therefore, the most severe effects of environmental conditions and nutritional deficiencies are seen in children. Death and sequelae can be prevented by early diagnosis.

Tunçbilek et al. evaluated the nutritional status of 3152 healthy preschool children from five geographical regions of Turkey [10]. Regional differences were found. Malnutrition prevalence was highest in the east (%38), lowest in the West (%10) and North (%14).

Çınar et al. evaluated 670 healthy children and reported that 15,2% of the patients were stunted and 11,8% of the patients were under-weighted [11]. The incidence of malnutrition in our study was found to be high compared to community screenings with healthy children in our country. This is because most of the patients in our study with malnutrition had chronic diseases or following in intensive care unit, and were hospitalized due to infectious diseases and/or neurological problems.

Different rates of malnutrition were reported in similar studies from different countries. Pawellek et al. evaluated 475 hospitalized children and they found that 24.1% of the patients were malnourished [12]. 17.7% of patients were mildly, 4.4% of patients were moderately, and 1.7% were severely malnourished. The largest proportion of patients with malnutrition was found with multiple diagnoses, mental retardation, infectious diseases and cystic fibrosis. 36% of patients with malnutrition have neurological problems in our study. Malnutrition is seen in patients with neurological disease due to oral motor dysfunction, gastroesophageal reflux, food rejection and increased energy requirements.

Hendricks et al. reported the frequency of hospital malnutrition was 24.5%, similar to our study [13]. Huong et al. reported 108 hospitalized children aged 6 months to 18, 9 years, and they found the overall rate of pediatric wasting was 19,0%, and stunting was (13,9%) [14]. Marino et al. found moderate malnutrition in 35% of 227 children hospitalized in a similar study [15].

Hospital malnutrition studies conducted with various classification from our country showed different malnutrition rates. Güleç et al. evaluated 260 children aged 1-36 months and 20.4% patients were defined as acute malnutrition, 19.2% as chronic and 7.7% as acute-chronic malnutrition according to Waterlow classification [16]. 123 patients with malnutrition were associated with infection and the most frequent infections determined were bronchiolitis (49%), pneumonia (34.8%) and acute gastroenteritis (5.4%). In our study, the most frequent infections were pneumonia and acute gastroenteritis like this study.

Öztürk et al. found the frequency of malnutrition at the time of admission to the hospital higher (31.8%) than in our study [17]. Also, Genel et al. evaluated 350 hospitalized children between 1 month and 6 years [18]. Malnutrition was found in 56.6% of the patients. Chronic malnutrition, acute malnutrition, and chronic plus acute malnutrition rates were 24.2%, 21.3%, and 1.9%, respectively.

Victoria et al. evaluated 802 children and reported a significant relationship between the income level of the family, the level of education of the father and the nutritional status [19]. Kızılyıldız et al. evaluated the relationship between socioeconomic status and malnutrition [20]. They evaluated 702 children from Van, Turkey. The prevalence of underweight, stunting, and wasting were 19.7%, 17.7%, and 16.2%, respectively. According to socioeconomic status; monthly family income was low in %19.6 of wasted children, %26 children with underweight and %36 in stunting. Monthly family income was low in 80% of malnourished children in our study.

It is known that infections are the predisposing factor for malnutrition. Malnutrition has also been shown to induce infection by reducing protein breakdown, cellular immunity, phagocyte function, complement system, secretory immunoglobulin A antibody level, and cytokine production in children. Acute gastroenteritis, respiratory tract infections, and recurrent infections lead to malnutrition by disrupting the feeding and increasing catabolism [21,22]. In our study, 20% of patients with malnutrition were hospitalized due to an infection. Five patients had sepsis, and septic shock in addition to primary disease and one patient had nosocomial pneumonia.

The prevalence of malnutrition in intensive care unit patients varies between 30% to 50% [ 23-25]. Malnutrition can cause complications, and that may lead to an increase in the length of stay, morbidity, and mortality. Twelve patients (48%) with malnutrition were followed in intensive care unit in our study.

In conclusion, high rates of malnutrition were detected in hospitalized patients; therefore nutritional status should be carefully assessed at the moment of hospitalization to reduce the mortality rate, and patients should be given immediate nutritional support.

Acknowledgement

All authors thank the patients and their families for their participation in this study.

Scientiﬁc Responsibility Statement

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Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

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Evaluation of mean platelet volume in patients with different degree of coronary collateral development

Ozge Kurmus 1, Turgay Aslan 1, Ozgur Kirbas 2, Cemal Koseoglu 3, Tolga Han Efe 4, Mehmet Bilge 5

1 Department of Cardiology, Ufuk University Faculty of Medicine, Ankara, 2 Department of Cardiology, Yuksek Ihtisas University, Ankara, 3 Department of Cardiology, Tokat State Hospital, Tokat, 4 Department of Cardiology, Dıskapı Yıldırım Beyazıt Education and Research Hospital, Ankara, 5 Department of Cardiology, Ataturk Education and Research Hospital, Ankara, Turkey

DOI: 10.4328/JCAM.5252 Received: 29.07.2017 Accepted: 06.09.2017 Published Online: 06.09.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 23-6

Corresponding Author: Ozge Kurmus, Department of Cardiology, Ufuk University Faculty of Medicine, Ankara, Turkey. GSM: +905055253318 E-Mail: ozge_kurmus@yahoo.com

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Aim: Coronary collateral vessels are an alternative source of blood supply to a myocardial area jeopardized by ischemia. As some patients have poor collaterals despite significant stenosis, it is thought that multiple factors affect collateral development beside coronary artery disease severity. Mean platelet volume is an indicator of platelet activation. Increased mean platelet volume is found to be related to worse prognosis in the coronary artery disease. In this study, we aimed to investigate the relationship between mean platelet volume and coronary collateral development. Material and Method: Patients with total occlusion in at least one coronary artery were enrolled in this study. Coronary angiography images of 367 patients without a history of revascularization were evaluated retrospectively, and coronary collateral development was graded according to Rentrop classification. Patients were divided into two groups based on Rentrop classification. Rentrop grade 0-1 was regarded as poor collateral development, and Rentrop 2-3 was regarded asgood collateral development. Mean platelet volume was compared between these two groups. Results: Poor collateral development was found in 236 patients (64.3%), and good collateral development was found in 131 patients (35.7%). There was no statistically significant difference in mean platelet volume levels between two groups (9.9±1,2 fL and 10.3±1.3 fL p=0,228). The 3-vessel disease was found to be a predictor of good collateral development (p=0.024). Discussion: In this study, it was found that there was no relationship between mean platelet volume and coronary collateral development.

Keywords: Coronary Collateral Development; Mean Platelet Volume; Coronary Artery Disease

Full Text

Introduction

Platelets play an important role in the pathogenesis of coronary artery disease (CAD). Their reactivity is a key issue and platelet size, simply measured by mean platelet volume (MPV), is an indirect marker of platelet reactivity [1,2]. Large platelets have a greater content of granules, higher thrombotic potential, increased thromboxane synthesis and serotonin release [3-5]. It has been reported that elevated MPV is associated with increased mortality following myocardial infarction and increased cardiovascular events in patients undergoing either an elective or urgent percutaneous coronary intervention [2,6].

Coronary collateral vessels serve as an alternative source of blood supply to an ischemic myocardium. Poor collateral development was found to be associated with larger infarct size and mortality in CAD patients [7,8]. One of the well-established determinants of collateral formation is coronary artery stenosis, but poor collateral development despite significant stenosis suggest that multiple mechanisms contribute to collateral formation [9]. Some mediators such as nitric oxide (NO), vascular endothelial growth factor, thromboxane, prostacyclin take part in the formation of collateral vessels [10-12].

In this study, we aimed to evaluate the relationship between MPV and coronary collateral formation in CAD patients.

Material and Method

The present study is a retrospective cross-sectional study. Between July 2011 and August 2012, 367 patients who underwent coronary angiography at our institution were enrolled in this study. All patients underwent coronary angiography because of suspicion of CAD based on their symptoms or diagnostic tests. Patients with at least one totally occluded major epicardial coronary artery were included in the study. Demographic and clinical data including age, gender, the prevalence of DM, hypertension, dyslipidemia, smoking history, and clinical presentation were obtained from all patients. Exclusion criteria were as follows: previous coronary revascularization history, history of malignancy or inflammatory disease, evidence of infectious disease, severe hepatic, or renal insufficiency, receiving anticoagulants and having congenital or acquired blood disorders. Also, patients with incomplete data were excluded. The study was approved by the local ethics committee.

Venous peripheral blood samples for complete blood count were drawn from patients undergoing elective (following a fasting period of 12 hours) or urgent coronary angiography (on admission). Blood samples were taken into standardized, EDTA containing tubes. Platelet parameters including count and MPV were determined by Beckman Coulter LH 780 Hematology Analyzer. Measurements were completed within one hour of blood sampling to avoid the EDTA induced platelet swelling with time.

Angiographic Procedure and Coronary Collateral Grading

Coronary angiography was performed via the femoral artery for all patients using the Judkins technique. Coronary stenosis degree, infarct related artery (IRA), and coronary collateral grading were estimated by two independent cardiologists who were blinded to the clinical information and laboratory parameters of the patients. Patients with at least one coronary artery with a total occlusion were enrolled in the study. Coronary collateral development was graded according to Rentrop classification: 0= no filling of any collateral vessel; 1= filling of the side branches of the the artery to be perfused by collateral vessels without visualization of the epicardial segment; 2= partial filling of the distal epicardial segment by collateral vessels; 3= complete filling of the distal epicardial segment by collateral vessels. Rentrop 0-1 was graded as poor collateral development, and Rentrop 2-3 was graded as good collateral development [13].

Statistical analysis

The Kolmogorov–Smirnov test was used to evaluate normal distribution. Continuous variables were expressed as mean ± standard deviation (SD), and categorical variables were defined as numbers and percentages. Student’s t-test or oneway analysis of variance (ANOVA) was used to compare continuous variables. Differences in the distribution of categorical variables were assessed using chi-square analysis. The best predictors of the poor collateral development were evaluated by multiple logistic regression analysis. Any variable whose univariable test had a p value <0.25 was accepted as a candidate for the multivariable model along with all variables of known clinical importance. Adjusted odds ratios and 95% confidence intervals (CIs) were also calculated. The results were considered significant when the p value was <0.05.

Results

The mean age of the study population was 61.6±12.4, and 74% of the patients were male. 94 patients had a diagnosis of stable angina pectoris, 97 patients had unstable angina pectoris or non-ST elevation myocardial infarction, 176 had ST elevation myocardial infarction. Of the 367 patients, 131 patients (35.7 %) had good collateral development, and 236 patients (64.3 %) had poor collateral development. The two groups did not differ for age, gender, diabetes mellitus, hyperlipidemia, hypertension, and smoking history. The demographic and laboratory characteristics of the groups are shown in Table 1.

Mean MPV was 10.0±1.3 fL, and the mean platelet count was 248.2±64 (1000/μL). The mean MPV was 10.3±1.3 fL in the good collateral group and 9.9±1.2 fL in the poor collateral group. There was no difference regarding mean MPV between two groups (p=0.228). Platelet count was not different between two groups (p=0.083). White blood cell count was higher in the poor collateral group than good collateral group (p=0.021). There were more patients with 3-vessel disease among the patients with good collateral development compared to patients with poor collateral development (p=0.016). In multivariate analysis, three vessel disease was found to be a predictor of good collateral development (odds ratio 0.595, 95%CI: 0.380-0.933, p=0.024).

Discussion

In our study, we investigated whether MPV is related to collateral development in patients with CAD. We found that the MPV levels were not related to coronary collateral development.

A well developed coronary collateral limits the ischemia, reduce the size of myocardial infarction, preserve left ventricle function, and has a favorable impact on the prognosis of patients with coronary artery disease [8,14]. Collateral vessels are a valuable source for alternative blood supply to ischemic myocardium especially in case of unachievable revascularization. But, there is notable variation in the degree of coronary collateral development. Collateral development is a multifactorial process, and it is important to define the factors that facilitate collateral development.

Platelets play a crucial role in the pathogenesis of atherosclerotic complications, and they are important targets for the treatment of coronary artery disease. MPV is an indirect marker of platelet activity. Larger, metabolically, and enzymatically more active platelets have greater prothrombotic features [5]. Elevated MPV was associated with worse clinical outcomes in patients with CAD [2]. Whether platelets with elevated MPV affect outcomes for worse by collateral formation or not hasn’t been explained clearly.

Previous studies about this issue are controversial. In a study of patients with the acute coronary syndrome, high MPV on admission was found to be associated with the presence of coronary collateral formation [15]. In contrast, in another study, elevated MPV was found to be a predictor of inadequate collateral development [16]. Some studies revealed that MPV levels were not related to coronary collateral development [17-19]. We also found that there wasn’t any significant relation between the collateral formation and MPV. Our study differed from the studies mentioned above in some aspects. Patients with >%50, >%80 or >%90 stenosis were enrolled in some of the previous studies. As the variations of the severity of the stenosis may affect collateral formation, we enrolled patients with at least one totally occluded major coronary artery. Also, there is a difference in classification of patients according to Rentrop classification. Rentrop 2-3 collaterals were accepted as good collateral formation in our study, whereas only Rentrop 3 was accepted as adequate collateral development in some studies.

In a study by Tan et al. platelet activation was measured by soluble CD40 ligand, soluble P-selectin, and soluble glycoprotein V. They reported that the correlation between the degree of collateralization and these platelets activation markers was not significant [20]. Thromboxane A2 and serotonin have been shown to cause vasoconstriction of the collateral vessels [21]. Large platelets have a greater content of granules, increased thromboxane synthesis and serotonin release. It is possible that activated platelets within collateral vessels could cause vasoconstriction and decrease collateral flow. It has been reported that platelet activating factor caused a decrease in coronary collateral flow with the participation of thromboxane A2 [12]. It has been reported that serotonin blocker augments flow reserve of the collateral circulation in anginal patients [22]. Collateral development is a multifactorial process, and the further studies are required to understand the role of activated platelets in collateral formation.

Conclusion

In conclusion, MPV levels were not related to coronary collateral development in a group of patients with either stable coronary artery disease or acute coronary syndrome.

Our study has some limitations. First, it is a retrospective study. Because of its retrospective design, there were no available data about previous antiplatelet drug use. It is possible that previous usage of antiplatelet drugs may have modulated MPV levels. Secondly, angiographically visible collaterals represent only a fraction of the total collateral vessel amount.

Animal and human rights statement

No animal studies were carried out by the authors for this article. The study was approved by the institutional ethics committee. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.’

Scientiﬁc Responsibility Statement

Animal and human rights statement

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

References

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Ozge Kurmus, Turgay Aslan, Ozgur Kirbas, Koseoglu, Tolga Han Efe, Mehmet Bilge. Evaluation of mean platelet volume in patients with different degree of coronary collateral develop. J Clin Anal Med. 2018;9(1):23-26

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Comparison of locking plate and cephalomedullary nailing in unstable proximal femur fractures

Recep Öztürk 1, Şefik Murat Arıkan 2

1 Department of Orthopaedics and Traumatology, Polatlı Public Hospital, 2 Department of Orthopaedics and Traumatology, Ankara Oncology Hospital, Ankara, Turkey

DOI: 10.4328/JCAM.5250 Received: 28.07.2017 Accepted: 15.08.2017 Published Online: 15.08.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 18-22

Corresponding Author: Recep Öztürk, Polatlı Public Hospital, Ankara, Turkey. GSM: +905054634794 E-Mail: ozturk_recep@windowslive.com

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Aim: The aim of this study is to compare the treatment results of unstable pertrochanteric femur fractures with proximal femur locking plates (PFLP) and cephalomedullary nailing (CMN). Material and Method: Between 2012 – 2016, 36 patients (with mean age 60.1 +/- 19.9 std) (between 18-90) of which 25 were male (%69) and 11 were female (%31) were retrospectively analyzed. Patients were divided into two groups. There were 12 patients in the first group who undergone CMN, and there were 24 patients in the second group who undergone PFLP. Results: The proximal lateral cortex fracture occurred in one patient of CMN group, fusion was achieved in 11 patients (91%). In PFLP group, mechanic failure occurred in one patient, pseudoarthrosis occurred in one patient, and fusion was achieved in 22 patients (91,6%). There was no infection in CMN group, and in PFLP group infection was seen in 3 patients (12,5%) of which 2 were deep and 1 was a superficial infection. DVT occurred in 2 patient in CMN (16,6%) and 1 patient in PFLP group (4,1%). Discussion: CMN and PFLP treatment results in patients with unstable femur pertrochanteric fractures were both satisfactory; surgery time, peroperative blood transfusion need, postoperative hospitalization time, mechanical failure and reoperation rates were similar.

Keywords: Hip Fracture; Intertrochanteric Femur Fracture; Locked Plating; Intramedullary Nailing; Internal Fixation

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Introduction

Unstable proximal femur fractures are problematic fractures in surgical treatment, and they are difficult to reduce and sustain the fixation [1]. Even if it is seen in all age groups, it is mostly seen in elderly patients (low energy trauma like falling) and young people (high energy trauma like falling from a high level and traffic accident) [2]. Recently, CMN has been the standard treatment due to fewer complication rates than hip nails in unstable proximal femur fractures [3]. However, in fractures in which the fracture line is extending through trochanter major, there are some difficulties in reduction and nail placement. Moreover, there may be secondary trochanteric or femoral shaft fracture, peroneal nerve injury, malrotation, instability, varus deformity, malunion or nonunion [4].

Recently, to minimize the possible complications, PFLP’s which possess high pullout strength and stable strength with constant angle [4]. The advantage of locking plates is that it allows achieving stable fixation at various angles and leads to less footprint compared to large proximal lag screws [5]. However, high level of failure rates even with experienced surgeons and hands has risen doubts about PFLP [3]. PFLP, just like CMN fixation, in the proximal femur fractures have been used for years. The aim of this study is to compare CMN and PFLP treatments in unstable intertrochanteric/subtrochanteric femur fractures regarding surgery duration, blood transfusion need, complications, and frequency of reoperation retrospectively.

Material and Method

Patients who have unstable femur pertrochanteric fractures (AO/OTA 31A3) treated surgically between 2012-2016 were included. Exclusion criteria were pathologic fractures, age less than 18 and follow-up period less than 6 months. All the subjects gave their informed consent before their inclusion in the study. The principles outlined in the Declaration of Helsinki were followed.

The clinical and radiologic data of the patients at the first application, peroperative and the last control examination were retrospectively evaluated. The reviewed demographic data were the time elapsed from injury to surgery, surgical procedure type (osteosynthesis with a proximal femoral nail (Smith and Nephew; Texas, USA) or proximal femoral locking plate fixation [4.5 mm locking compression plate (LCP) Proximal Femur Plate, Smith and Nephew; Texas, USA]) and complications.

The clinical and radiologic data follow up data were evaluated postoperative 3rd and 6th weeks and 45 days later than the last one. All surgical procedures were in supine position. Traction table was not used in any of the patients.

All the patients in both groups were mobilized in the 1st postoperative day. In CMN group, the patients were mobilized by applying the recommendation of the surgeon without laying on the healing extremity in the first 6 weeks or just partially laying on. All the patients were mobilized as much as they can tolerate from the 6th postoperative week. In PFLP group, patients were mobilized without laying on the healing extremity in the first 6 weeks and laying on as much as they can tolerate in the following 3 months.

The patient characteristics were gender, age, diabetes mellitus, smoking history, comorbidities, and the time elapsed until surgery.

Mechanical failure was described as 10-degree alignment loss or 2 cm shortness. Nonunion was described as no union in the postop 6th month or no progressive fusion in the control examinations. Superficial wound infection is defined as an infection of the wound, in which there is no evidence that the infection extends to the site of the implant, deep wound infection, defined as infection around the implant.

36 patients all with unstable femur fracture (OTA 31A3) were included in the study. In the first group CMN was applied to 12 patients (11 subtrochanteric, 1 intertrochanteric fracture) with a mean age of 56.2±21.3 (range 18-86) and in the second group, PFLP was applied to 24 patients with a mean age 62.1±19 (range 32-90).

All the operations were carried out by the same team of experienced surgeons. In all cases, antibiotic prophylaxis and low molecular weight heparin prophylaxis were provided. The radiographs of the cases were obtained via taking anteroposterior and lateral graphies 24-72 hours after the operations, and these graphies were analyzed regarding reduction and implant position.

Complications were counted as varus collapse, implant related problems, secondary fractures, deep or superficial infection, cardiac ischemia, pneumonia and urinary tract infection.

All patients were followed for at least 6 months. Mean follow up period for all patients was 17.1 months (6-41), it was 15.2 (6-24) in CMN group and 18.1 months (6-41) in PFLP group.

The variables between CMN and PFLP groups were compared via univariate analysis. A p value of 0,05 was considered significant. Confidence interval (CI) was chosen as 95% in the study. All statistical analyses were performed using SPSS 22.0 statistical software (SPSS, Chicago, IL, USA).

Results

There was no difference between two groups regarding age, gender, time elapsed until surgery, diabetes mellitus and comorbidities. Patients in CMN group were 4 years older than those of PFLP group (58.2vs. 62.1) (Table 1).

Mean time elapsed till the surgery after the injury was 1.7 days in PFLP group (0-5 days) and 1.5 days (0-3 days) in CMN group. Mean surgery time in CMN group was 101 minutes (70-145 minutes) and 103 minutes (80-180 minutes) in PFLP groups. Intraoperative blood transfusion need in CMN group was 0,2 unit and 0,4 unit (0-1) in PFLP groups. Hospital staying time after surgery in PFLP group was 5,3 days (2-9 days) and 4,2 days (2-8 days) in CMN group (table 1).

The intraoperative and postoperative blood transfusion need were 0,2 unit (0-1 unit) and 0,9 unit (0-2 unit) and 0,4 unit (0-1 unit) and 1 unit (0-3 unit) in CMN and PFLP groups relatively.

While in 11 patients (91% of CMN group) fusion was achieved, in one patient proximal lateral cortical femur fracture occurred and conservatively followed because patient relatives did not accept an operation and the patient died 6th month postoperatively. In 1 patient in PFLP group mechanic failure (varus collapse) and pseudoarthrosis in another patient occurred. Hemiarthroplasty and pseudoarthrosis surgery + iliac autogenous grafting + fixation revision were applied relatively. Fusion was achieved in 22 patients (91,6%) (Table 1) (figure 1 and 2).

There was no infection in any of the patients in CMN group. On the other hand, in PFLP group infection was seen in 3 patients (12,4%) (2 with deep and 1 with superficial infection). Superficial infection was treated using irrigation + debridement, and deep infection was treated by irrigation + debridement + implant removal. The patient treated with implant removal healed with a 1 cm shortness. DVT occurred in 2 patients (16,6%) of CMN group and 1 patient (%4,1) of PFLP group. Malunion was not seen in any patient of any group. As a result, 3 cases (25%) of CMN group and 6 cases (25%) of PFLP group developed major complications. There was no statistically significant difference in mortality in the first year (P> 0.05). All the patients except for a deceased patient, are under our follow up in all groups.

Discussion

Unstable proximal femur fractures are difficult entities even for experienced surgeons [2]. To achieve a successful treatment, the clinical, anatomical and biomechanical characteristics of the region must be well known [3, 6].

Although these fractures are seen in all age groups, they are mostly seen in elders with low energy injuries (falling) and in young people with high energy injuries (traffic accident or falling from a high level) [2]. In our study, the number of high energy trauma was 14, and low energy trauma was 22. The mean age was 60, but the age interval was 19-90.

In the surgical method of implant selection in unstable proximal femur fractures, many treatment methods were suggested in the past, and there were still discussions about that [2-4, 7-10]. In one of them that is 95 degree wedged condylar plates, fusion rate had been found 92-100 %, malunion was 13-24%, the late union was 6-19%, nonunion was 3-12%, and implant failure was 6-24% [9].

The intertrochanteric femur fractures in which the fracture lines reach the lateral femoral cortex beyond the vastus ridge of trochanter major, show some unique mechanical and anatomic features that have been found to cause insufficient results when sliding hip screws were used. For these type of fractures, the standard method of treatment has become cephalomedullary nails [6, 10].

Fusion rate was 87-100 %, the nonunion rate was 3-13%, malunion rate was 3-6%, and implant failure rate was 0-4% in the first and second generation CMNs [9, 11].

The disadvantages of IMNs were the high frequency of need for intraoperative fluoroscopic imaging, difficulties in techniques in implementation, the need for experienced surgeons, the difficulty in implant removal in need, and implantation difficulty especially in fractures extending trochanter major and fossa piriformis [7, 9, 10, 12].

High level of complication rates after surgical fixation in unstable proximal femur fracture in elder patients brought up primary hip prosthesis implementation [8,9]. However, due to luxation risk, high level of mortality, complication risks in case of revision, internal fixation was suggested for young and active elder people [8, 9, 13].

In last ten years, locking plates have been in use for proximal femur fracture treatments [3, 10]. Locking plates have some advantages such as letting multiple angularly stable fixation points in the proximal femur while leaving a smaller footprint by keeping more bone reserve after implantation in comparison with the large proximal leg screws. Biochemical studies have implied that stronger and more stable fixation was achieved with locking plates in comparison with other angulary stable implants [5].

There are very few studies in the literature comparing CMN and PFLP. In these studies, high level of failure rates of locking plates more than expected had risen worries.

In recent times, in a study that Collinge et al. had done, all the 111 proximal femur fractures were treated with proximal femur anatomic plates, and 41,4% treatment failure was found. Which were fixation loss, malunion, nonunion, surgical malalignment and deep infection or the combination of these [1].

In another study that includes 114 patients, Mirbolook et al. compared PFLP and CMN. Infection in 27% of all patients, side device failure in 12%, malunion in 11% and nonunion in 8% and combinations of these in various rates were seen. Mirbolook et al. have suggested in this study that plate or IMN selection may not be a factor for the complications developed [2].

Kanthimathi et al. have suggested that the talent of the surgeon and the selection of right technique may decrease the complications [14].

In this study, we compared CMN and PFLP treatments in unstable intertrochanteric/

subtrochanteric femur fractures retrospectively regarding surgery time, blood transfusion need, surgery results, complications and reoperation frequency.

In our study, there are similar union rates as 91% in CMN group and 91,6% in PFLP group. In the face of literature, PFLP just like CMN may be evaluated as having satisfactory union rates.

Similarly, Streubel et al. reported 33% cumulative failure in 12 months in patients with 31A3 intertrochanteric fracture. The high rate of failure in this study can be attributed to the use of two or three screws for fixation of the proximal part [3]. The better results with PFLP in our study were thought to be due to the usage of at least 4 screws of which at least 3 of them with 6,5 mm size were implanted into proximal.

In general, as we evaluate treatment complications of subtrochanteric femur fractures, high rate of nonunion (3-12%), malunion (13-24%), implant failure (6-24%) and infection (8-20%) may be counted. Moreover, mostly in elder people, there are complications as dvt, pneumonia, UTI, pressure ulcers, feeding insufficiency [9]. In our study in PFLP group, pseudoarthrosis in one patient and varus collapse in another patient occurred. In CMN group, lateral femoral cortex fracture occurred in one patient. Besides that, one patient in each group developed DVT.

Even if there was no infection mentioned in the condylar screw and IMN fixation, 8-20% infection was reported in cases of the 95-degree condylar plate [9]. In our study, likewise literature, while no infection was seen in IMN group, 3 cases were seen in PFLP group as 2 of them with deep and 1 of them with superficial infection.

In PFLP group, for 5 patients totally (2 deep infections, 1 superficial infection, 1 pseudoarthrosis, 1 varus collapse) and in CMN group for 1 patient reoperation was planned.

In one patient only, proximal lateral cortical femur fracture occurred and conservatively followed because patient relatives did not accept an operation and the patient died at the 6th postoperative month. Totally 2 patients, one in CMN and one in PFLP groups each, died in the first year of follow ups.

There were some limitations of this study. The sample size was small, and it led to low comparison power in comparing group characteristics. There was no significant difference found between two groups regarding age, smoking, injury mechanism and diabetes mellitus. However, there may be a significant difference with a larger sample size.

Conclusion

Both the results of CMN and PFLP in patients with unstable proximal femur fractures are satisfactory; surgery time, peroperative transfusion need, postoperative hospital staying time, mechanical failure and reoperation rates are similar. Infection rates and reoperation need were higher in PFLP group than that in CMN group. PFLP group was a good alternative for CMN in proximal femur fractures.

Scientiﬁc Responsibility Statement

Animal and human rights statement

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

References

1. Collinge CA, Hymes R, Archdeacon M, Streubel P, Obremskey W, Weber T, et al. Unstable proximal femur fractures treated with proximal femoral locking plates: a retrospective, multicenter study of 111 cases. J Orthop Trauma. 2016;30(9):489-95.

2. Mirbolook A, Siavashi B, Jafarinezhad AE, Khajeh JS, Farahmand M, Roohi RM, et al. Subtrochanteric fractures: comparison of proximal femur locking plate and ıntramedullary locking nail fixation outcome. Indian J Surg. 2015;77:795-8.

3. Streubel PN, Moustoukas M, Obremskey WT. Locked plating versus cephalomedullary nailing of unstable intertrochanteric femur fractures. Eur J Orthop Surg Traumatol. 2016;26(4):385-90.

4. Azboy I, Demirtaş A, Gem M, Cakır IA, Tutak Y. A comparison of proximal femoral locking plate versus 95-degree angled blade plate in the treatment of reverse intertrochanteric fractures. Eklem Hastalik Cerrahisi. 2014;25(1):15-20.

5. Kim JW, Oh CW, Byun YS, Oh JK, Kim HJ, Min WK, et al. A biomechanical analysis of locking plate fixation with minimally invasive plate osteosynthesis in a subtrochanteric fracture model. J Trauma. 2011;70(1):19-23.

6. Haidukewych GJ, Israel TA, Berry DJ. Reverse obliquity fractures of the intertrochanteric region of the femur. J Bone Joint Surg Am. 2001; 83(5):643–50.

7. Uzer G, Elmadağ NM, Yıldız F, Bilsel K, Erden T, Toprak H. Comparison of two types of proximal femoral nails in the treatment of intertrochanteric femur fractures. Ulus Travma Acil Cerrahi Derg. 2015;21(5):385-91.

8. Görmeli G, Korkmaz MF, Görmeli CA, Adanaş C, Karataş T, Şimşek SA. Comparison of femur intertrochanteric fracture fixation with hemiarthroplasty and proximal femoral nail systems. Ulus Travma Acil Cerrahi Derg. 2015;21(6):503-8.

9. Yilmaz E, Karakurt L, Güzel H, Serin E. Evaluation of treatment results with the 95-degree AO/ASIF angular plate in subtrochanteric femur fractures. Eklem Hastalik Cerrahisi. 2005;16:42-8.

10. Sadowski C, Lubbeke A, Saudan M, Riand N, Stern R, Hoffmeyer P. Treatment of reverse oblique and transverse intertrochanteric fractures with use of an intramedullary nail or a 95 degrees screw-plate: a prospective, randomized study. J Bone Joint Surg Am. 2002; 84(3):372–81.

11. Edwards SA, Pandit HG, Clarke HJ. The long gamma nail: a DGH experience. Injury. 2000; 31:701-9.

12. Rebuzzi E, Pannone A, Schiavetti S, Santoriello P, De NU, Fancellu G, et al. IMHS clinical experience in the treatment of peritrochanteric fractures. The results of a multicentric Italian study of 981 cases. Injury. 2002;33:407-12.

13. Stoffelen D, Haentjens P, Reynders P, Casteleyn PP, Broos P, Opdecam P. Hip arthroplasty for failed internal fixation of intertrochanteric and subtrochanteric fractures in the elderly patient. Acta Orthop Belg. 1994;60(1):135-9.

14. Kanthimathi B, Narayanan V. Early complications in proximal femoral nailing done for treatment of subtrochanteric fractures. Malays Orthop J. 2012; 6(1):25–9.

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The role of thorax-ct in mediastinal staging of the nonsmall cell lung cancer, revive our memories

Özgur Ömer Yıldız 1, Serdar Özkan 2

1 Department of Thoracic Surgery, Yildirim Beyazit University, Yenimahalle Education and Resarch Hospital, Ankara, 2 Department of Thoracic Surgery, Medova Hospital, Konya, Turkey

DOI: 10.4328/JCAM.5244 Received: 27.07.17 Accepted: 06.09.2017 Published Online: 06.09.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 13-7

Corresponding Author: Serdar Özkan, Göğüs Cerrahisi, Medova Hastanesi, Şeyh Şamil Mah, Dosteli Cad, No:52/1 Selçuklu, Konya, Türkiye. GSM: +905065339979 E-Mail: drozkan78@yahoo.com

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Aim: In this study, the role of thorax-CT was examined in evaluating intrathoracic lymph node in patients diagnosed with preoperative Non-Small Cell Lung Cancer (NSCLC). This study aims to review our existing knowledge on thorax-CT, which is the first examination method used in the evaluation of lung masses and to discuss its performance in mediastinal staging based on data of patients in Turkey. Material and Method: 510 cases selected by the criteria identified between January 2009 and July 2011 were included in the study. Lymph nodes, their sizes in thorax-CT, histological type of the tumor, removed mediastinal lymph nodes and pathology results were examined. Results: As a result of the statistical analyses, the sensitivity of thorax-CT in detecting metastatic intra-thoracic lymph nodes was calculated as 75.7%, specificity 41%, negative predictive value (NPV) 85% and accuracy 48.4%. NPV and positive predictive value (PPV) were also calculated for N1 and N2 diseases. False positive rate of thorax-CT in detecting N1 disease was calculated as 53.6%, and the false negative rate was calculated as 28.7%. The false positive rate in detecting N2 disease was 64.6%, and the false negative rate was 20%. Discussion: While thorax-CT is essential in mediastinal staging in NSCLC, we believe that thorax-CT alone is not sufficient and needs to be supplemented with other scans and invasive methods. Due to the increased health costs, the waste of time and labor due to the use of more than one scan, Positron Emission Tomography and CT should be used more frequently in especially in lung cancer.

Keywords: Non-Small Cell Lung Cancer; Lymph Node; Mediastinal Staging; Tomography

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Introduction

Lung cancer, with increasing incidence and mortality rates, is one of the most important health problems in the World and almost one-third of deaths from cancer are due to lung cancer. Only 15% of the patients can survive for 5 or more years after being diagnosed [1].

In non-small cell lung cancer (NSCLC), when diagnosed 50% of the patients have mediastinal lymph node involvement and less than 33% are suitable for surgical resection [2,3]. To increase the success rate of surgical treatment, early diagnosis is crucial. For accurate staging of NSCLC, location, and size of the primary tumor (T factor), regional lymph nodes (N factor) and distant metastasis (M factor) need to be identified. For this, methods such as Thorax CT, Magnetic resonance imaging (MRI), Scintigraphy, Ultrasonography, Positron Emission Tomography (PET) are used [4].

In patients without distant metastasis, mediastinal lymph node involvement is the most important factor in determining treatment and prognosis. Therefore, accurate evaluation of mediastinal lymphatic metastasis is crucial in preoperative stage [5]. Thorax-CT, which is used as the initial method for identification of metastatic mediastinal lymph node, has limited sensitivity and specificity in showing metastasis in enlarged lymph nodes [6]. On the other hand, mediastinoscopy which is the ‘gold standard’ with excellent sensitivity and specificity rates in mediastinal lymphatic staging has the disadvantage of being invasive.

The aim of this study is to determine sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and accuracy rates of thorax-CT in detection of metastatic intrathoracic lymph nodes in patients with NSCLC, to assess the need for invasive methods through additional scanning methods and to refresh our knowledge, by comparing thorax-CT findings for intrathoracic lymph nodes and histopathological results obtained through invasive methods.

Material and Method

Cases who were diagnosed with NSCLC and who underwent thorax-CT and PET-CT, and surgery for treatment and/or staging between January 2009 and July 2011 were retrospectively reviewed. The study included all surgical cases who underwent histopathological examination apart from fine needle aspiration biopsy. 28 cases out of 538, who underwent chemoradiotherapy were excluded from the study.

Preoperative assessment of all cases included anamnesis, physical examination, respiratory function tests, electrocardiography, blood biochemistry and hemogram tests, coagulation tests, postero-anterior and lateral lung graphics, thorax-CT and PET-CT. Tests and invasive procedures were performed based on TNM staging. Age, gender, preoperative diagnostic tests, location of the mass, enlarged intrathoracic lymph node on thorax-CT (>1cm), SUVmax values of masses and all intrathoracic lymph nodes in PET-CT, operations performed, lymph nodes which were sampled/excised in operation, size of the tumor lesion, histopathological examination results of sampled lymph nodes and tumor type of all cases were recorded in the database.

Statistical analysis of the data was conducted with SPSS for Windows 11.5. Continuous variables were summarized by mean and standard error or by median (smallest – largest), and categorical variables were summarized by frequency and percentage.

Pearson’s Chi-Square test and Fisher’s exact test were used for assessing the significance of thorax-CT results in detecting metastatic and non-metastatic lymph nodes according to the histopathological results.

Using Pearson’s Chi Square or Fisher’s Exact tests, thorax-CT results were compared for every lymph node station to assess whether they are determinate in differentiating metastatic and non-metastatic lymph nodes according to histopathological results. Sensitivity, specificity, positive and negative predictive values, and accuracy rates were calculated to assess the diagnostic indicators.

Logistic regression analysis was undertaken to assess the role of thorax-CT results in differentiating metastatic and non-metastatic lymph node groups. Odds ratio and 95% confidence intervals were calculated for both examination results. Spearman’s correlation test was used to assess the presence of any significant correlation between continuous variables.

P values less than 0.05 were considered significant.

Results

The study included 510 cases diagnosed with NSCLC preoperatively, who underwent thorax-CT, PET-CT, and surgery for staging/treatment between January 2009 and July 2011. 459 of the cases (90%) were male, and 51 (10%) were female. Their ages ranged between 26 and 87 with a mean age of 59,2+9,0.

A diagnosis of NSCLC was made preoperatively for 263 cases (51,5%) by transthoracic fine-needle aspiration biopsy, for 245 cases (48,1%) by bronchoscopic biopsy and for 2 cases (0,4%) by video-assisted thoracoscopic biopsy.

83 cases (16,3%) were diagnosed with diabetes mellitus. Since the presence of DM did not have any significant correlation in the evaluation of PET-CT results, the patients underwent scan according to their pre-scan blood glucose levels. The mean blood glucose level was 103 mg/dl (80-150mgr/dl).

The cases who underwent neoadjuvant chemoradiotherapy were not included in the study.

Among 510 cases which underwent surgery for staging and/or treatment after diagnosed with NSCLC, lobectomy was performed for 285 cases (55,9%), pneumonectomy for 196 cases (20,8%), wedge resection for 6 cases (1,2%), exploration for 1 case (0,2%), sleeve resection of the left main bronchus for 1 case (0,2%) and mediastinoscopy for 111 cases (21,7%).

In the analysis of tumor localizations, right lung tumor lesion was detected in 286 cases (56%), and left lung tumor lesion was detected in 224 cases (44%). 132 of the right lung tumors (25,8%) were in the upper right lobe, and 22 of them (4,3%) were in the right middle lobe, and 61 (11,9%) were in the lower right lobe, and 71 (13,9%) were in the hilar region.

The size of the masses ranged between 0,4 and 20 cm with a mean size of 4 cm. SUVmax value of masses ranged between 0 and 42,8. Mean SUVmax value of the masses was calculated as 12,6.

According to the histopathological examination to assess the tumor lesions based on the cell types, the most common carcinoma was squamous carcinoma with 229 cases (44,9%), second one was adenocarcinoma with 162 cases (31,8%) and 36 cases (7,1%) had adenosquamous carcinoma, 17 cases (3,3%) had large cell carcinoma and 12 cases (2,4%) had sarcomatoid carcinoma. A number of cases, which were not divided into a type, was 54 (10,6%). Such cases were mostly the ones diagnosed with preoperative NSCLC and which only underwent mediastinoscopy.

The size of intrathoracic lymph nodes in thorax-CT and histopathological examination results for lymph nodes sampled/excised in operation were evaluated separately for each intrathoracic lymph node station. Lymph nodes measuring more than 1 cm in the short axis diameter that showed enlargement in thorax-CT were evaluated as metastatic, while lymph nodes under 1cm in size were evaluated as benign. Following the comparison of the results for the lymph nodes that were verified histopathologically and lymph nodes that were classified as metastatic or benign based on the lymph node size in thorax-CT, sensitivity, specificity, PPV, NPV, and accuracy rates were calculated for all intrathoracic lymph node stations.

The role of thorax-CT in determining the situation of intrathoracic lymph nodes and mediastinal staging in NSCLC was assessed for every station one by one (Table 1). Also, a general statistical analysis was conducted for N1 and N2. N1 lymph node stations which were assessed as benign in thorax-CT and histopathologically examined are 159. 130 of these cases had benign N1 lymph nodes, and 29 of them had metastatic N1 lymph nodes. There were 222 cases assessed as metastatic in thorax-CT and examined. Pathological results showed that 150 of these cases had benign N1 lymph nodes and 72 of them had metastatic N1 lymph nodes. Statistical analysis of the results showed that sensitivity of thorax-CT in NSCLC was 71,3%, specificity 46,4%. PPV 32,4%, NPV 81,8% and accuracy 53% (p: 0,002) (Table 2).

According to the thorax-CT scans of N2 lymph node stations, N1 lymph node stations which were assessed as benign in thorax-CT and histopathologically examined are 165. According to the pathological results of these cases, lymph nodes were benign in 146 cases and metastatic in 19 of them. The number of cases, which had metastatic N2 lymph node station in thorax-CT and examined was 343. According to the pathological results, lymph nodes in 267 of these cases were benign and metastatic in 76 cases. Following the assessment of N2 lymph node stations; sensitivity of thorax-CT in identifying the situation of lymph nodes was calculated as 80%, specificity 35,4%, PPV 22,2%, NPV 88,5% and accuracy as 43,7% (p: 0,004) (Table 2).

Multiple variable logistic regression analysis was undertaken to assess the role of thorax-CT and PET-CT with a SUVmax value of 2.5 for each lymph node station in differentiating metastatic and non-metastatic lymph node groups according to histopathological examination results. Odds ratio and 95% confidence intervals were calculated for both examination results. It was found that PET-CT had more statistically significant results (p<0.001) (Table 3).

False positive and false negative rates of thorax-CT and PET CT in mediastinal staging of NSCLC were calculated separately for each lymph node (Table 4, Table 5).

False positive and false negative rates were also calculated for N1 and N2 diseases. False positive and false negative rate of thorax-CT in identifying N1 disease were calculated as 53.6% and 28.7% respectively. In the detection of N2 disease, the false positive rate was calculated as 64.6%, while the false negative rate was found as 20%.

Discussion

Size and localization of masses, lymph node involvement and metastasis are among the factors affecting survival in lung cancer patients as in all oncological diseases [7].

To be able to decide on surgical resection in NSCLC patients, preoperative lymph node involvement must be evaluated, and staging must be done.

Non-invasive and invasive methods are used in evaluating mediastinal lymph nodes. Among the non-invasive staging methods are thorax-CT and PET-CT which are the main radiological scanning methods. Among the invasive diagnosis methods are transbronchial lymph node needle biopsy, endobronchial ultrasound-guided lymph node biopsy, esophageal endoscopic ultrasound guided lymph node biopsy, transthoracic lymph node biopsy, mediastinoscopy, mediastinotomy, VATS, and thoracotomy.

Thorax-CT which is one of the most commonly used non-invasive scanning method in routine cases can be used to find out localization and size of the tumor, its relationship with other anatomic structures (invasion, etc.) and its resectability. While enlarged mediastinal lymph nodes detected in thorax-CT can be shown anatomically, it can not be understood whether these lymph nodes are metastatic or not. In thorax-CT, lymph nodes with a short axis diameter measuring more than 1cm are considered as the limit regarding mediastinal lymph node metastasis. However, due to infection and benign pathologies it is difficult to differentiate enlarged lymph nodes and metastatic lymph nodes. The probability of metastasis in a mediastinal lymph node with a small diameter in thorax-CT is more than 20%. The sensitivity of thorax-CT in mediastinal lymph node staging is 57%, and specificity is around 82% [8].

There is a wide literature on the role of thorax-CT in detecting mediastinal lymph node metastasis. As a result, it was found that thorax-CT is not sufficient on its own to detect metastatic intrathoracic lymph nodes. The results of these studies on the diagnostic performance of thorax-CT are presented here (Table 6).

According to a study conducted by Dunagan et al]. in 2001 with 72 patients, the sensitivity of thorax-CT in mediastinal lymph node metastasis was found as 50%, specificity as 87%, PPD as 56%, and NPV as 84% [9]. Another study conducted in the same year by Pieterman et al]. calculated sensitivity as 75%, specificity as 66%, PPD as 50% and NPD as 85% [10]. According to the meta-analysis conducted by Toloza et al. in 2003 on the diagnostic performance of non-invasive mediastinal staging methods based on 20 studies with 3438 patients, sensitivity of thorax-CT in detecting mediastinal lymph nodes metastasis was 57%, specificity 82%, PPV 44% and NPV 17% [6] (Table 6). In our study, the sensitivity of thorax-CT in detecting metastatic intrathoracic lymph nodes was found as 75.7%, specificity as 41%, PPV as 27.3%, NPV as 85% and accuracy as 48.4%.

Diagnostic performance of the methods was also evaluated according to the meta-analysis data published by Toloza et al. in 2003 based on a comparison of invasive and non-invasive mediastinal staging methods in NSCLC. In this study, while sensitivity of thorax-CT was calculated as 57%, specificity as 82%, NPV as 83%, PPV as 56% and accuracy as 28%, PET-CT, which is a non-invasive method had 84% sensitivity, 89% specificity, 93% NPV, 79% PPV and 32% accuracy. The sensitivity of transbronchial needle aspiration biopsy, which is an invasive method, was calculated as 76%, specificity as 96%, NPV as 71%, PPV as 100% and accuracy as 70%. On the other hand, the sensitivity of endoscopic ultrasound guided fine needle aspiration biopsy had sensitivity was found as 88%, specificity as 91%, NPV as 77%, PPV as 98% and accuracy as 69%. The sensitivity of mediastinoscopy which is considered as the gold standard in mediastinal staging is 81%, specificity is 100%, NPV is 91%, PPV is 100% and accuracy is 37% (Table 7) [6].

However, despite the high diagnostic performance rates for invasive staging methods, due to disadvantages including mortality and morbidity rates, albeit low, and limited sampling of lymph nodes, less invasive or non-invasive methods need to be used.

Patients with NSCLC who have longest survival rates and successful treatment rates are the ones who had an early diagnosis and underwent surgical resection. Therefore, the main feature that is crucial in both non-invasive and invasive methods used for preoperative mediastinal staging is the staging of N factor with the most accurate results.

There are ongoing studies across the world to find the fastest, most accurate, and least invasive method by making a comparative analysis of different mediastinal staging methods. Our study aims to demonstrate the role of thorax-CT, which has become the standard scanning method, in mediastinal lymphatic staging. We aim to determine whether non-invasive methods could serve as an alternative to invasive methods in mediastinal lymphatic staging.

Thorax-CT plays a central role in the diagnosis and staging of lung cancer. It gives useful information with regards to the localization of the tumor in the thorax, its size, resectability, its relationship with anatomic structures (T state) and detection of metastatic mediastinal lymph nodes (N2 state). Lymph nodes measuring more than 1cm in the short axis diameter are considered as suspicious regarding metastasis. However, while the rate of detection of metastasis in non-pathological small lymph nodes could be 15-20%, in enlarged lymph nodes, the rate for detection of non-metastasis could be 40% [11, 12].

In our study, sensitivity of thorax-CT in detecting intrathoracic lymph nodes is 75,7%, specificity is 41%, PPV is 27,3%, NPV is 85% and accuracy is 48,4%. False positive and negative rates were identified or N1 and N2 diseases. False negative rate and false positive rate of thorax-CT in identifying N1 disease were calculated as 53.6%, and 28.7% respectively. False positive and false negative rate for identifying N2 disease were found as 64.6% and 20% respectively.

Our study found that specificity of thorax-CT and PPV were lower than other studies (Table 6). While this is statistically meaningful, we believe that it is due to the bigger size lymph nodes caused by infectious and granulomas diseases, which are common in Turkey.

Following the statistical analysis, it was found that thorax-CT on its own is not an effective scanning method in detection of metastatic intrathoracic lymph nodes however it is still an important method regarding identifying the anatomic localization of the mass, its resectability and its relation to surrounding tissues. While thorax-CT could be performed before the additional invasive methods in mediastinal staging of the lymph nodes, its use together with the non-invasive methods would also make a positive impact on the diagnostic performance indicators.

This study aims to review our knowledge on thorax-CT which is the most commonly used scanning method in lung mass and to discuss its role in mediastinal staging based on the data derived from patients in Turkey.

Although thorax-CT is an indispensable scanning method for mediastinal staging in NSCLC, it must be noted that its sole use is not sufficient and it should be supplemented with other scanning techniques and invasive methods. Following our study which aimed to refresh our knowledge, we would like to emphasize that considering the increasing health costs and the waste of time and labor due to the use of more than one scanning method, the combination of PET and CT must be resorted more. As the data on the use of PET and MR combination in several health centers in recent periods become available, we believe that there might be different developments about the use of non-invasive methods in mediastinal staging.

Scientiﬁc Responsibility Statement

Animal and human rights statement

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

References

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Ozgur Omer Yildiz, Serdar Ozkan. The role of thorax-CT in mediastinal staging of the nonsmall cell lung cancer, revive our memories. J Clin Anal Med. 2018;9(1):13-17

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The effect of oxaliplatin on heart tissue of the rats

Ufuk Eryılmaz 1, Saliha Aksun 2, Buket Demirci 3

1 Department of Cardiology Medical Faculty, Adnan Menderes University, Aydin, 2 Department of Medical Biochemistry, Medical Faculty, Katip Celebi University, Izmir, 3 Department of Medical Pharmacology, Medical Faculty, Adnan Menderes University, Aydin, Turkey

DOI: 10.4328/JCAM.5223 Received: 18.07.2017 Accepted: 29.08.2017 Published Online: 29.08.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 9-12

Corresponding Author: Ufuk Eryılmaz, Department of Cardiology, Faculty of Medicine, Adnan Menderes University, 9100, Aydın, Turkey. GSM: +905359819712 E-Mail: drufukeryilmaz@gmail.com

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Abstract

Aim: This study investigates the cardiotoxicity of Oxaliplatin (OXA) on rat heart by using oxidative stress parameters on myocardium and troponin I and S100A1 levels of serum. Material and Method: Acute OXA treatment (4 mg/kg/1st, 3rd and 5th days) has been administered to the 6-8 months old rats. The heart and serum samples were obtained at 7th and 14th days of the study. Chronic OXA treatment was (4 mg/kg/two days of week/4 weeks) administered, rats were sacrificed and heart and serum samples were obtained at the 28th day and at the 2st day following the completing administration of drugs. Results: The results of all OXA treatment group’s antioxidant levels and serum cardiotoxicity markers; troponin I and S100 A1 levels were not significantly different compared to the control group (p>0.05). Discussion: OXA did not produce significant oxidative myocardial damage when given 4 mg/kg in acute and chronic administration. Oxa treatment seems safe in terms of cardiotoxicity.

Keywords: Cardio-Oncology; Oxaliplatin; S100A1; Troponin I

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Introduction

Chemotherapeutic agents are thought to have the potential to damage cardiac tissue. The risk and mechanism of chemotherapy-induced cardiotoxicity may vary depending on the type and severity of the anticancer regimen. Numerous chemotherapeutic drugs may cause adverse cardiovascular side effects such as arterial hypertension, heart failure, and thromboembolic events. Anthracyclines (eg., doxorubicin, epirubicin, daunorubicin, idarubicin) have been extensively studied because of the high incidence of cardiac insufficiency due to cardiotoxicity and significant cardiovascular effects [1,2]. However, cardiotoxicity may also occur with other chemotherapeutic agents including alkylating agents (cyclophosphamide, ifosfamide), platinum agents, antimetabolites (5-fluorouracil, capecitabine), antibiotics (mitoxantrone, mitomycin, bleomycin) and antimicrobial agents (taxanes) [3].

Although cardiotoxicity has been reported by oxidative stress induced by cisplatin-related reactive oxygen metabolites from platinum group chemotherapeutics, fewer studies have been reported on oxaliplatin(OXA) cardiotoxicity [4,5,6].

For this reason, in this study; we studied whether cardiotoxicity was present in the acute or chronic administration of OXA or not. If such a side effect is present, the recycling of this toxicant was assessed with biochemical markers of damage.

Material and Method

Animals and experimental design

Wistar rats, 6-8 months old albino male, were obtained from Animal Care and Research Unit of Adnan Menderes University (ADU, Aydin, Turkey) all experiments were performed according to the principles and guidelines of ADU Animal Ethical Committee’s approval. This study mainly planned to assess the ototoxic effect of OXA, but the remained tissues have been evaluated on cardiotoxicity to decrease the animal number used in medical researches (HADYEK, 64583101/2014). 4 mg/kg OXA (Eloxatin®, Sanofi, U.S.) have been diluted in 5% glucose solution just before intraperitoneal (i.p.) administration. The experimental groups were as follows:

Control (n=7): The rats in this group were administered 5% glucose solution i.p.

Acute OXA treatment (n=7): Animals with OXA treatment on the 1st, 3rd and 5th days of the study, animals were sacrificed at day 7.

Acute OXA treatment + waiting period (n=7): Animals with OXA treatment on the 1st, 3rd and 5th days of the study, animals were sacrificed at day 14 to see the OXA effect one week later after drug cessation.

Chronic OXA treatment (n=7): OXA was injected two days in a week (Monday and Thursday) for 4 weeks, and the rats were sacrificed on the 28th day.

Chronic OXA treatment + waiting period (n=7): OXA was injected two days in a week (Monday and Thursday) for 4 weeks. The rats were sacrificed 21 days after the completion of the injections.

In each group at the end of the study time, the blood was withdrawn by cardiac puncture and the tissues taken out were immediately placed on ice, under the anesthesia of Ketamine and Xylazine (50 mg/kg and 5 mg/kg, respectively).

Determination of oxidant/antioxidant parameters in heart tissues

Dissected heart tissues were immediately rinsed in ice-cold phosphate-buffered saline. Tissues were homogenized (2000 rpm/min for 1 min, 1/10 w/v) using a Teflon-glass stirrer (IKA Overhead Stirrer; IKA-Werke GmbH & Co. KG, Staufen, Germany) in 10% 150 mM phosphate buffer (pH 7.4) in an ice bath. The homogenate was centrifuged (HettichZentrifugen, Mikro 200 R, Tuttlingen, Germany) at 6000 g for 10 min at 4ºC. The supernatants were frozen at -80ºC (Glacier Ultralow Temperature Freezer, Japan) until analyzed.

Protein concentrations in supernatants were measured by aspectrophotometer (Shimadzu UV-1601, Kyoto, Japan) usingcommercially available kits by the Biuret method (Archem Diagnostic Ind. Ltd., Istanbul,Turkey) and the results are expressed as mg/ml protein.

Malondialdehyde(MDA) level

The concentrations of MDA were determined according to the method of Yoshioka et al. [7]. The tissue homogenate was used for the lipid peroxidation estimation, which was applied by measuring the formation of thiobarbituric acid reactive substances (TBARS). Absorbance was measured by using a spectrophotometer at 532 nm. The concentration of MDA was calculated by the absorbance complex (absorbance coefficient ε=1.56×105/M/cm) and expressed as nmol/mg tissue protein.

Total glutathione (GSH) level

The amount of GSH in supernatants were measured according to the method described by Tietze [8]. The supernatant was used to determine GSH using 5,5’-dithiobis (2-nitrobenzoic acid) (DTNB). Absorbance was spectrophotometrically determined at 412 nm. The results were determined by comparison with a standard aqueous solution of GSH (Sigma ChemicalCo., St. Louis, Missouri, USA) and expressed as mg/g tissue protein.

Catalase (CAT) activity

CAT activity was determined according to the method of Bergmeyeret al. [9], and was measured spectrophotometrically at 240 nm. The principle of the assay was based on the determination of the rate constant of hydrogenperoxide decomposition by the CAT enzyme and expressed as k/mg tissue protein.

Superoxidedismutase (SOD) activity

SOD activity was determined according to the method of Sun et al. [10], and the absorbance was measured at 560 nm by a spectrophotometer. The principle of this method is based on the inhibition of nitro blue tetrazolium reduction by the xanthine on xanthine oxidase system as a superoxide generator. SOD activity was then measured by the degree of inhibition of this reaction and the results are shown as U/mg tissue protein.

All these enzyme activity assays were analyzed in duplicate, and were averaged.

Determination of Troponin and S100A1 in serum

The blood was centrifuged (HettichZentrifugen, Mikro 200 R, Tuttlingen, Germany) at 10000 g for 10 min at 4ºC and the serum kept at -80ºC until analyzed. Serum Troponin I levels were determined with immunoassay on Advia Centaur CP (Siemens, Germany) autoanalyzer. Rat serum S100A1 levels were determined by using rat protein S100A1 ELISA kit (Sensitivity 1.56 ng/ml; Cusabio Biotech, China), according to the manufacturer instructions and studied on Bioctechautomatic Elisa plate reader (USA). The optical density of each well was determined within 5 minutes using a micro plate reader set to 450 nm.

Statistical analysis

Statistical package program SPPS 20 (IBM Corp. released 2011; IBM SPSS Statistics for Windows, Version 20.0, Armonk, NY: IBM Corp.) was used to evaluate the data. Variables, mean ± standard deviation and median (Maximum-Minimum) percentage and frequency values were used. Also, the homogeneity of the variances from the preconditions of the parametric tests was checked by the “Levene” test. The assumption of normality was checked by the “Shapiro-Wilk” test. For three or more group comparisons, One-way analysis of variance and multiple comparisons of Tukey HSD test was used and if it was not provided by this test Kruskal Wallis, and Bonferroni-Dunn test of multiple comparison tests were used.

If the relationship between the two variables does not satisfy the parametric test prerequisites, the Spearman Rho Correlation Coefficient is used. Statistical significance level was accepted as p <0.05.

Results

Tissue SOD, CAT, GSH and MDA levels

None of the results in all acute, acute waiting, chronic and chronic waiting OXA treatment group’s SOD, CAT, GSH and MDA levels were significantly different from the control group (p>0.05). These antioxidants have shown that OXA does not cause oxidative damage in our study protocol (Table 1).

Serum cardiac parameters

Troponin I and S100 A1 level

Serum cardiotoxicity markers; troponin I and S100 A1 level changes in all of the acute, acute waiting, chronic and chronic waiting OXA treatment groups were not significantly different compared to the control group(p>0.05 )(Table 2).

Discussion

Cardiotoxicity was investigated by using biochemical parameters. First, the (anti)oxidative status of the heart tissue has been evaluated after the exposure of OXA. Secondly, troponin I levels have been assessed as well-known markers of cardiac injury to clarify whether OXA is harmful. Thirdly, the S100A1 level of serum was investigated as a possible new marker of onco-cardiology.

The heart muscle is highly perfused, therefore it’s exposure is only possible by high concentration drugs. Based on the tissue levels of SOD, CAT, GSH and MDA results of this study, the administration of OXA in these acute and chronic routes did not severely induce oxidative stress in the heart. Troponin I and S100 A1 levels in the serum as indicators of cardiac damage were also not detected in the control group, indicating that cardiotoxicity did not occur.

SOD and CAT are primary antioxidant enzymes. Hydrogen peroxide (H2O2), superoxide anion (O2) and hydroxyl radicals are biologic products of reduction of oxygen (O2) molecules; these antioxidant enzymes protect the organism against these radicals [11,12].

In an experimental animal study of the hepatic toxicity of OXA in vitro conditions by Tabassum et al., mitochondria were incubated with OXA. Similar to our study, SOD antioxidant enzyme was also evaluated. Unlike our study, SOD enzyme was found to be significantly higher than the control in the group treated with 500 μmolOXA [13].However, in our study, by not determining increased SOD enzyme in heart tissue in any of the acute and chronic administration groups at 4 mg/kg dose we found that OXA didn’t have a cardiotoxic effect.

OXA in combination with 5-fluorouracil was found to cause cardiotoxicity due to elevated troponin I in an animal study [14]. However, as a platinum group chemotherapeutic agent, OXA is reported to have a much lower toxic effect than cisplatin [15]. However, OXA alone has not been studied for toxic effects on heart tissue. In our study, we did not detect the cardiotoxic effect of OXA in serum and tissue markers. However, not studying the cardiotoxic effect at different doses is one of the limitations of our study.

In an experimental animal study in which cardiotoxicity was assessed by platinum-based chemotherapeutics, in accordance with the literature, a significant increase in MDA levels in comparison with the control group was found while SOD and GSH were found to be significantly decreased in mice given 10 mg/kg IP cisplatin [16]. In our study, there was no significant difference between OXA and these enzymes compared to the control group.

It has been reported that S100A1 is most abundant in cardiomyocytes [17] and finds in the extracellular compartment after heart ischemia [18]. In our previous study, we have shown the disruption of S100 A1 after exposure of lapatinib or trastuzumab therapy [19]. Beside of the Troponin I and MDA levels, S100 A1 level did not give any significant changing value.

As a conclusion, OXA did not produce significant oxidative myocardial damage when given 4 mg/kg. We clearly demonstrated that OXA treatment alone did not show detrimental effect when given acute and chronic administration.

Human Rights Statement: All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Animal Rights Statement: Nonapplicable.

Conflict of Interest Statement. The research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Funding: The research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Scientific Responsibility Statement: The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.

Scientiﬁc Responsibility Statement

Animal and human rights statement

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

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19. Eryılmaz U, Demirci B, Aksun S, Boyacıoğlu M, Akgullu C, Ilgenli TF, et al. S100A1 as a potential Diagnostic biomarker for assessing cardiotoxicity and implications for chemotherapy of certain cancers. 2015. Doi.org/ 0.1371/journal.pone.0145418.

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Ufuk Eryilmaz, Saliha Aksun, Buket Demirci. The effect of Oxaliplatin on heart tissue of the rats. J Clin Anal Med. 2018;9(1):9-12

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An evaluation of the relaibility of videos on youtube related to shoulder dislocation reduction methods

Cem Yalın Kılınc 1, Ahmet İmerci 1, Umut Canbek 1, Ulaş Akgün 1, Rabia Mihriban Kılınc 2, M. Nazım Karalezli 1, Nevres Hürriyet Aydoğan 1

1 Department of Ortopedic Surgery, Mugla Sitki Kocman University, Medicine Scholl, 2 Department of Radyology, Mugla Sitki Kocman University, Medicine Scholl, Mugla, Turkey

DOI: 10.4328/JCAM.5211 Received: 10.07.2017 Accepted: 21.08.2017 Published Online: 21.08.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 5-8

Corresponding Author: Cem Yalın Kılınc, Department of Ortopedic Surgery, Mugla Sitki Kocman University, Medicine Scholl, Mugla, Turkey. T.: +90 2522115228 F.: +90 2522141326 E-Mail: cykilinc@gmail.com

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Aim: We aimed to determine the availability of videos on YouTube related to shoulder dislocation reduction manoeuvres, which could be used for training. Material and Method: Of a total 536 videos, 389 were excluded, primarily because they were not related to shoulder dislocation. The remaining 147 videos were watched and evaluated. Results: Of the 147 videos evaluated in this study, 70 had been uploaded by relevant healthcare personnel such as doctors. The number of views was determined as mean 89149.19 (min-max: 7-2593041), the median time was 4.44 minutes (min-max 0.18-51.58 mins), the maximum number of video uploads was made with 41 videos in 2015, and in 93 videos real people were used. When the videos were watched, 98 videos were deter-mined to show manoeuvres applied accurately. When the videos were evaluated according to the correct application, a statistically significant relationship was observed between the number of views, the upload date and the accuracy of the manoeuvre shown (p≤0.05). A significant difference was also found between the accuracy of the video and who uploaded it (p:0.058). No statistically significant relationship was determined between the lengths of the videos, to whom the manoeuvre was applied and accuracy. (p: 0.213- 0.625 respectively). Discussion: The results of this study showed that videos related to shoulder dislocation uploaded to YouTube are not %100 accurate and instructive. Therefore, taking these videos as a guide in training may result in the application of incorrect manoeuvres causing some complications during the shoulder dislocation reduction. Videos which showed more than one manoeuvre were observed to be more accurate than those showing a single manoeuvre.

Keywords: Shoulder; Dislocation; Anterior Shoulder Dislocation; Reduction; Manoeuvre; Youtube Videos; Education; Joint Dislocation; Reduction; Joint Reduction; Social Network

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Introduction

The most commonly encountered dislocations in the Emergency Department are shoulder dislocations [1,2,3]. Of all shoulder dislocations, 85%-90% are towards the anterior [4,5]. Shoulder dislocations are usually treated by orthopedic specialists, but when an orthopedic surgeon is not available, for example in rural areas or at certain times of the day, it can also be performed by the emergency doctors or auxiliary health personnel. During shoulder dislocation reduction, various complications may be encountered. The most common complications can be listed as proximal humerus fracture, axillary nerve and/or axillary artery injury, and brachial plexus injury [6]. The person who performs the reduction needs to be aware that these complications may occur and because of these complications, the instructions for shoulder reduction must be taken seriously.

The instructions related to shoulder dislocation reduction are given in the Faculties of Medicine. It is necessary to see how the theoretical information, which is an important step of the instructions, is applied and to consolidate the method thoroughly. Visual learning can be performed by learning from the orthopedic specialists and may be augmented by videos on social networks on the Internet.

YouTube is a social network where people can upload and share videos easily. As it is easy to access, this increases the prevalence, but the possibility of incorrect information contained on the videos may lead to the rapid spread of misinformation [7,8,9].

In this study, we watched 537 videos that can be accessed from a total of 3350 videos by searching “shoulder dislocation reduction” on ‘’YouTube’’, which is a social network. It was aimed to determine the accuracy of videos related to reduction manoeuvres published on this search engine, which can be easily accessed and to determine whether or not the manoeuvre was performed correctly.

Material and Method

This study comprised an assessment by 6 Orthopedics and Traumatology Specialists trained in shoulder dislocation, who watched videos about shoulder reduction manoeuvre installed on YouTube. To create a common language, the most common reduction manoeuvres were repeated before the study. Techniques such as Hippocrates [10], Kocher [3,11,12,20], Traction-counter traction [12], Milch technique [13,14,17], scapular manipulation techniques [15,16] and Stimson technique [17,18] were revised. The videos in which these techniques were not used, were assessed under the title of “others”. First of all, by typing ‘’shoulder dislocation reduction manoeuvre’’ on ‘’https://www.youtube.com’’ search engine, the videos found were assessed according to conformity and sufficiency. During the assessment of the videos, situations considered as the exclusion criteria of the videos are shown in Table1.

While watching the videos, the video uploaders (uploaders are official institutions, public institutions such as Universities related to this subject), professionals such as Doctors-Paramedics related to this subject, unknown uploaders, Agencies (News), Companies (companies advertising courses) were noted. Also, the duration of the video, the number of views, and to whom the manoeuvre was applied ( applied to a person, to a model, or both) were analyzed.

All the videos were analyzed by six independent Orthopedics and Traumatology Specialists to assess whether or not the applications in the videos were performed accurately. While watching the videos, when there was disagreement between the evaluators about the evaluation of the application, the video was re-evaluated by 2 Professors of Orthopedics. The compliance and accuracy of the videos were assessed by the previous transmissions [10,17].

The statistical analyses of all the data obtained from this study were made using “Statistical Package for Social Sciences for Windows 20’’ software. Quantitative variables were stated as the mean ± standard deviation (SD) and categorical variables as number (n) and percentage (%). Frequency analysis was applied. While the comparisons among the groups were analyzed, conformity to a normal distribution was assessed. For the comparison of normally distributed data, the parametric Independent samples test was used, and where distribution was not normal, the non-parametric Mann-Whitney U-test was applied. A value of p≤0.05 was considered statistically significant.

Results

When ‘’shoulder dislocation reduction manoeuvre’’ was searched on ‘’You Tube’’ search engine, 3360 results were found. On every page, there were 20 uploaded videos and a total of 28 pages. One page could not be opened, so a total of 26 complete pages and 16 videos on the 27th page resulted in a total 536 videos which were watched (There was only permission to watch 536 of 3360 videos).

Following the exclusion criteria, a total of 389 videos (72.57%) were excluded, primarily because they were not related to shoulder dislocation, leaving 147 videos for evaluation (Table 2).

Of the 147 videos included for analysis, 42 were uploaded by an unknown uploader, 70 were uploaded by relevant healthcare personnel such as doctors, and 23 were uploaded by official institutions. The number of views was mean 89149.19 (min-max: 7-2593041), the median duration was 4.44 (min-max,0.18-51.58 mins), the most videos were uploaded in 2015 (n=41) and the least in 2006 (n=0) and in 93 videos, the manoeuvre was applied to people (Table 3). The data related to which manoeuvre or technique was used and how many times it was repeated in the video are shown in Table 3.

In 98 videos, the manoeuvre was determined to be applied accurately. When the videos were assessed according to the accurate application, a statistically significant relationship was determined between the number of views and the upload date and the accuracy of the video (p≤0.05). A close to a statistically significant relationship was determined between the uploader of the video and accuracy of the manoeuvre applied (p:0.058). No statistically significant relationship was determined between the video duration and to whom it was applied and accuracy ( p: 0.213, p: 0.625 respectively).

Of the watched videos, it was observed that few manoeuvres were shown. When the accuracy rate of the applied manoeuvres was evaluated separately, the Stimson technique was applied accurately in 10 videos, and in the 24 videos labeled as ‘other manoeuvres’, the manoeuvre was observed to be applied accurately (82.75%). Of the other manoeuvres, the Cunningham technique was applied most, and the accuracy rate was higher (15 patients, 87.7% accuracy). The traction-counter traction manoeuvre was determined to be applied accurately in 22 videos (78.57%), and the scapular manipulation manoeuvre was applied accurately in 14 videos (70%). Although the Kocher manoeuvre was the numerically most applied technique (n:32), the accuracy rate was 68.08%, the Milch manoeuvre was applied accurately in 19 videos (65.51%) and the most commonly known manoeuvre, the Hippocrates technique was applied accurately in only 15 videos (78%) (Table 4). More than one technique was used in 19 videos and in these videos all the techniques were applied accurately. (100%) (Table 4).

Discussion

The results of this study demonstrated that the uploaded videos on YouTube were not 100% accurate and instructive and therefore watching these videos, may result in incorrect manoeuvres of shoulder dislocation reduction causing complications. It was also seen that the videos in which a few manoeuvres were explained were more accurate than those demonstrating a single manoeuvre.

YouTube is a widely used social network where people upload videos and people can easily access these throughout the world. It has been used since 2005 and is so widespread that people access much information via a YouTube search. However, the widespread use may create problems regarding the accuracy and reliability of the videos. Many studies have been conducted on the reliability and accuracy of YouTube videos. For example, In a study by Yaylacı et al. assessing the accuracy and reliability of YouTube videos, cardiopulmonary resuscitation (CPR) and basic life support (BLS) were investigated, and it was reported that of 1994 videos uploaded, 1785 did not meet the study criteria, and only 209 videos conformed to the 2010 guidelines [9]. Thus it has been stated that few of these videos are suitable for training. In the current study, according to the data obtained in the same way, only 27.42% of all the available videos were about shoulder dislocation reduction manoeuvre. Thus, only one in four videos was meaningful for healthcare personnel to watch for training.

It was observed that from 2005 to 2015, the number of uploaded videos increased. Of the videos included in the study, 27.9% were uploaded in 2015, and 56.5% of all the videos included in the study had been uploaded in the last 3 years. As the number of published videos increased, so the accuracy of the videos was also observed to increase. This means that visual technology is used efficiently and has become increasingly common.

Murugiah et al. evaluated YouTube videos by performing BLS and CPR scans [9]. No relationship was determined between the length of the video, to whom the procedure was applied, the number of downloads and the accuracy of the video and that a high number of views did not indicate accuracy. In the current study, no statistically significant relationship was determined between the duration of the video and to whom the manoeuvre was applied, but in contrast to the previous study, it was determined that the videos with a greater number of views were those which demonstrated the procedure more accurately (p≤0,05).

In a study by Bezner et al., gastroschisis, diaphragmatic congenital hernia, pediatric inguinal hernias, and pectus excavatum were searched on YouTube [19]. The first 40 videos for each of the results in English were watched and scored, and it was reported that most of the videos were uploaded by medical professionals and these videos were more accurate than others. In the current study, when the uploaders of the videos were analyzed, although to a small degree, it was determined that the videos uploaded by official institutions and doctors were more reliable (p:0.058), which can be considered an anticipated result.

When the methods were observed separately, the accuracy rate of the Stimmson manoeuvre was 100%, and of other methods 82.5% (Cunningham manoeuvre 87.7%), Hippocrates manoeuvre 78.9%, traction-counter traction manoeuvre 78.57%, scapular manipulation manoeuvre 78.57%, Milch/Modified Milch manoeuvre 65.51%, Kocher manoeuvre 62.8%). Although the Kocher manoeuvre was the most applied manoeuvre, the applicability was deemed to be low. In all 19 videos where more than one manoeuvre was demonstrated, all the manoeuvres were seen to be described and performed accurately. Therefore, except the Stimson manoeuvre, watching the videos for training purposes may cause problems in terms of learning. Only those videos in which more than one manoeuvre is explained should be considered suitable for training.

Conclusion

In the modern technological age, it is normal that the Internet is used as an educational tool. However, when used as a supplement to medical training, care must be taken to exclude material giving inaccurate information to thereby minimize errors in practice both for the patient and practitioner. If health-related videos were only published by relevant institutions or if the published videos of these institutions were prioritized, the problems would be reduced.

A significant limitation of this study was that when the YouTube search was made for “shoulder dislocation reduction manoeuvre’’, although there were 3360 results, we could only watch 536 of these videos. It could be considered that if a greater number of videos were watched, the results would be strengthened.

Scientiﬁc Responsibility Statement

Animal and human rights statement

Funding

None

Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

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Cem Yalın Kılınc, Ahmet İmerci, Umut Canbek, Ulaş Akgun, Rabia Mihriban Kılınc, M. Nazım Karalezli, Nevres Hürriyet Aydoğan. An evaluation of the relaibility of videos on youtube related to shoulder dislocation reduction methods. J Clin Anal Med. 2018;9(1):5-8

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An evaluation of the 10-year major osteoporotic and hip facture risk using the FRAX score in Erzurum

Ahmet İmerci 1, Nevres Hurriyet Aydoğan 1, Ali Aydın 2

1 Department of Orthopaedics and Traumatology, Mugla Sitki Kocman University, Faculty of Medicine, Mugla, 2 Atatürk University, Faculty of Medicine, Turkey

DOI:10.4328/JCAM.5202 Received: 05.07.2017 Accepted: 08.11.17 Published Online: 08.11.2017 Printed: 01.01.2018 J Clin Anal Med 2018;9(1): 1-4

Corresponding Author: Ahmet Imerci, Department of Orthopaedics and Traumatology, Mugla Sitki Kocman University, Faculty of Medicine, Mugla, Turkey. GSM: +905068935276 F.: +90 2522111345 E-Mail: ahmetimerci@hotmail.com

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Aim: The aim of this prospective study was to provide an estimation of the 10-year probability of the four major osteoporotic fractures using fracture risk evaluation scale (FRAX) and to review the risk factors for osteoporosis in males and females aged over 50 years in Erzurum, Turkey. Material and Method: An evaluation was made 1254 patients who presented at the Outpatient Clinics of State Hospital in 2013. Taking the risk factors and bone mineral density (BMD) values into consideration, and using the FRAX risk evaluation scale, the 10-year major osteoporotic (MO) and hip fracture risks were evaluated for all the participants. Results: While a significant difference was seen between the genders in respect of measurements of the osteoporosis (OP) major risk fracture with BMD determined as mean 7.4% in females and 5.77% in males, and without BMD, as 8.27% in females and 4.59% in males and without BMD, the hip fracture risk was 2.92% in females and 1.91% in males (p=0.016, p<0.001, p<0.001, respectively), no significant difference was determined in the hip fracture risk with BMD at 2.62% in females and 3.05% in males (p=0.517). With an increase in body mass index (BMI), there was a decrease in the OP risk (p<0.001). With BMD, the MO fracture risk groups were formed of 84.5% low risk, 10.5% moderate risk and 5% high risk. Discussion: If BMD values were taken as the basis for medical treatment in Turkey, the use of scanning tests and fracture risk evaluation scales such as FRAX would be useful. However, to be able to better determine the extent of OP and the fracture risk in the general population and maybe to be able to determine threshold values which may be different in our population, there is a need for further multi-center studies including greater numbers of patients.

Keywords: Osteoporos; Bone Mineral Density; Fracture; Frax; Erzurum

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Introduction

Osteoporosis (OP) is a systemic skeletal disease, characterised by low bone mineral density (BMD) and destruction of the micro-structure of the bone tissue, which causes increased bone fragility and risk of fracture [1]. In most people, the disease shows no symptoms until the development of a fracture and therefore, early diagnosis is extremely important. BMD measurements are used in diagnosis and follow-up and to obtain these measurements, the Dual X-ray absorptiometry (DEXA) method is accepted as the gold standard [2].

The fracture risk evaluation scale (FRAX) is a fracture evaluation tool developed by the World Health Organisation (WHO) [2]. FRAX allows clinicians to calculate a definite 10-year risk for the patient of a hip or ‘major’ fractures (hip, wrist, humerus or spinal fractures). In a comparison of BMD alone, a higher differentiation has been shown at least 13% in the prediction of females suffering a future fracture [4]. The possibility is calculated using risk factors such as age, body mass index (BMI), previous fragility fracture, familial history of hip fracture, cigarette smoking, long-term use of oral glucocorticoid, rheumatoid arthritis, excessive alcohol consumption and other secondary OP causes. Individuals at high risk of OP and osteoporotic fractures can be identified with the determination of the risk factors. Thus, fractures can be prevented with modification of the risk factors [3, 5].

Early diagnosis of OP, identification of risk groups for early treatment and prevention, and determination of the risk before a fracture all play an important role in the prevention of morbidity and mortality associated with OP and in the reduction of healthcare costs. Therefore, the aim of this study was to determine cases of osteopenia and OP in the early stages by measuring BMD and to determine the 10-year fracture risk using the FRAX scale in patients presenting at our hospital.

Material and Method

In the study period of 2013, a total of 1254 patients aged over 50 years, with no previous OP treatment underwent a DEXA scan at State Hospital. BMD measurements were taken with a DEXA Hologic Q 2000 device of the posteroanterior lumbar spine (L1- L4) and hip (femoral neck). The machine calibrations, tests, controls, and phantom measurements were applied routinely by certified technicians. The participants removed outer clothing and were weighed and measured, then DEXA scanning was applied. The BMD values were evaluated with the T-scores defined according to the peak young adult bone density value. According to the WHO classification, patients with a T-score of ≤-2.5 were accepted as osteoporotic, those with scores of -1- -2.5 as osteopenic and those with a score of> -1 as normal [2]. Approval for the study was granted by the Research Ethics Committee of Ataturk University. Informed consent was obtained from all patients prior to inclusion.

Fracture Risk Evaluation Tool

The 10-year probability fracture can be automatically calculated using FRAX® scoring. Therefore, for the evaluation of fracture risk according to FRAX®, the required data was recorded on a questionnaire administered face-to-face. These data included age, gender, height, weight, previous fracture, hip fracture of a parent, smoking, glucocorticoid treatment, rheumatoid arthritis, secondary osteoporosis, alcohol intake and related clinical data. The web-based algorithm at http://www.shef.ac.uk/FRAX® was applied as the FRAX® algorithm (version 3.6) adapted for Turkey [3]. In this way, by entering and not entering the femoral neck (FN) T-score value for each patient, four different scores were obtained for major osteoporotic (MO) fracture risk and hip fracture risk. According to the National Osteoporosis Foundation in the USA (NOF) criteria, a FRAX® score of ≥20% for MO fracture or ≥3% for hip fracture is defined as a patient at high risk and these values are accepted as the threshold for intervention [5].

Statistical Analysis

The study data were analysed using SPSS for Windows version 20 (SPSS Inc, Chicago, IL, USA) statistics software. Continuous variables were stated as mean ± standard deviation (SD) and categorical variables as percentage (%). The relationships were compared between gender and demographic characteristics, and between T-scores and fracture risk. The relationship between BMI and the fracture risk with and without the BMD value was evaluated with the Pearson and Spearman tests. A value of p<0.05 was accepted as statistically significant.

Results

The mean age was determined as 64.97 years for females and 68.54 years for males. The BMI was calculated as 29.33 ± 5.19 for females and 25.70 ± 4.15 for males, and the difference was statistically significant (p<0.001).

The distribution of risk factors of the patients was previous fracture (37), parent hip fracture (22), current smoking (25), current glucocorticoid use (12), alcohol consumption (2), rheumatoid arthritis (8), and secondary OP (34). The most common cause of secondary OP was diabetes mellitus (32).

Of the total cases, 513 (40.9%) were determined as osteoporotic, 496 (39.5%) as osteopenic and 246 (19.6%) as normal. No statistically significant difference was determined between the genders in respect of the femoral neck T-scores (p=0.784). The lumbar 1-4 T-scores were statistically significantly lower in females than in males (p<0.001). While a significant difference was seen between the genders in respect of measurements of the OP major risk fracture with BMD determined as mean 7.4% in females and 5.77% in males, and without BMD, as 8.27% in females and 4.59% in males and without BMD, the hip fracture risk was 2.92% in females and 1.91% in males (p=0.016, p<0.001, p<0.001, respectively), no significant difference was determined in the hip fracture risk with BMD at 2.62% in females and 3.05% in males (p=0.517) (Table 1). With an increase in BMI, a decrease in the OP risk was determined both with and without BMD measurements (p<0.001) (Table 2).

With BMD, the MO fracture risk groups were formed of 84.5% low risk, 10.5% moderate risk and 5% high risk. For hip fracture risk with BMD, the rates were 88.2% low risk, 7.4% moderate risk and 4.4% high risk.

Discussion

In a study by Kutlu et al. [6], the frequency of OP and osteopenia were determined as 14.9% and 39.2% respectively. In another study, 57% of patients were determined as osteoporotic and 42% as osteopenic [7]. According to the results of the FRAKTURK study in Turkey by the Turkish Osteoporosis Association, which included participants aged 50 years and over in 12 regions, including Erzurum, osteopenia was determined in 50% of the participants and OP in 25% [8]. In a study conducted in the region of Thrace, OP was revealed to be a significant health problem as 1 in 4 individuals over the age of 55 years were osteoporotic. The prevalence in females was determined as 15.1% and in males over the age of 40 years, 10.7% [9]. Ipek et al. [10] determined the OP rate with DEXA as 31.8% in the L1-L4 vertebrae region, as 40.2% in the femoral neck and as 34.3% in at least one area of the L1-L4 vertebrae and/or the femoral neck. In the current study, 513 (40.9%) patients were determined as osteoporotic, 496 (39.5%) as osteopenic and 246 (19.6%) as normal.

In a previous study in Turkey, the probability of MO fracture was determined as 0.5%-12 % with BMD and as 0.1%-7.1% without BMD, and the risk of hip fracture as 0%-10% with BMD and as 0%-5.6% without BMD [6]. In another study evaluating the risk of fracture with FRAX, a high risk of MO fracture was determined in 9.5% of patients and a high risk of hip fracture in 30.4% (11). The fracture risk in females aged over 50 years was estimated with FRAX and the 10-year MO fracture, and hip fracture risk with and without BMD measurement was found to be 1.7%, 16.4%, and 2.3%, 16% respectively [12]. Tuzun et al. [8] found the mean 10-year MO fracture probability to be 6.0% and the hip fracture to be 2%. In another study in Turkey, the MO and hip fracture was determined as 5.5% andd 0.9% with BMD measurements and as 5.7% and 1.1% without BMD measurements [13].

The validity and reliability of the FRAX fracture risk scoring system have been investigated in studies made in different countries. In a multi-center retrospective study by Pedrazzoni et al. [14], the actual 10-year risk in postmenopausal females was reported to be 7.5% of the median value and 1.7% for the femoral fracture risk. Czerwinski et al. [15] reported the MO fracture probability as 9.9% when calculated without BMD measurements and 10.2% with BMD. In a study in Japan, Fujiwara et al. [16] reported that fracture risk was 5% in patients over the age of 50 years, and more than 20% in those aged over 80 years. Etinger et al. [17] calculated the 10-year hip fracture risk using the FRAX USA Model in patients aged younger than 65 years and the risk was reported as <40%. Leslie et al. [18] found a greater risk in females than males of both MO fracture and hip fracture. These results were similar to the findings of the current study. In the current study population, the fracture risk with both measurement methods was determined as 4.59%-8.27% for MO fracture risk and as 1.91%- 3.95% for hip fracture risk. As expected, the probability was higher in females than males.

One of the risk factors of OP is body structure [19]. A significant relationship was found between BMI and OP in a study by Pinar et al. [20] of females aged >45 years. Similarly, Kutlu et al. [6] determined a statistically significant relationship between BMI and OP. However, Robitaille et al. [21] reported OP in 11% of cases with BMI <18.5 and 7.5% of those with BMI of ≥30. A statistically significant correlation was determined in the current study between BMI and OP, and as BMI increased, so the OP risk decreased (p<0.001). In a prospective study of males aged >50 years, Burger et al. [22] showed a strong relationship between an increase in BMI and high BMD. Obese patients were compared with those of normal values in a study by Mesci et al. [23], and it was reported that the T-scores of the obese patients were higher and the FRAX fracture risk was lower.

Bastos-Silva et al. [24] identified high fracture risk (≥20%) as 0.75% using BMD and as 1% without the use of BMD values. In relation to hip fractures, a high fracture risk (≥3%) was determined in 5.22% with BMD, and in 11.44% without BMD. In the current study, according to the NOF threshold criteria (≥20%), this group constituted 5% MO fracture risk and 4.4% hip fracture risk with FRAX with BMD [25]. Demir et al. [19] found high risk to be <1% with and without BMD measurements for both fracture risks.

That some significant fracture risk factors are not included (falls, bone turnover, style of dressing, lifestyle), that BMD is limited to the femoral neck, that the fracture risk may be over or underestimated, and that it is not used in patients who have been treated, are some of the disadvantages of the FRAX model [26-28]. Despite low BMI values in Turkey, OP is widespread, and there is a great risk of osteoporotic fractures. Taking into consideration that the BMD and T-score can be affected by many factors, it has been reported that as the data used in the FRAX model in Turkey are insufficient and out-of-date, there is a need for it to be revised [8, 27, 29].

To provide a simple calculation of the risk factor with the use of the FRAX risk evaluation scale, which has been developed for each country with specially prepared data and consideration of the risk factors, patients at high risk can be identified in the early stages and appropriate OP treatment will be cost-effective. If medical treatment in Turkey were based on BMD values, fracture risk evaluation scales such as FRAX and the use of scan tests would be beneficial.

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Conflict of interest

None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.

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Ahmet İmerci, Nevres Hurriyet Aydoğan, Ali Aydın. An evaluation of the 10-year major osteoporotic and hip facture risk using the frax score in Erzurum. J Clin Anal Med. 2018;9(1):1-4

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