Assessing the Rates of Major Complications in Combined Mini-incision Microscopic Varicocelectomy

Study Overview
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Brief Summary
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The purpose of this study is to determine the rates of major post-varicocelectomy complications (Recurrence, Hydrocele and Testicular Atrophy) in patients operated with a new method named Combined Mini-incision Microscopic Varicocelectomy. The study hypothesis is that using this method will lead to less major complications of recurrence, hydrocele, and also less incidental injuries to the arteries that will result less testicular atrophy

Detailed Description
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The sample is selected from the patients who were referred to our center for surgical treatment of varicocele. Most of them were diagnosed after being evaluated for infertility. All of them were operated by a single experienced and expert microscopic surgeon. Informed consent is received from all of the possible candidates in accordance to national and Declaration of Helsinki guidelines. Selection of patients for undergoing Combined varicocelectomy was done during the operation due to the nature of including criteria. In this method after making an incision at inguinal level, veins are evaluated and if the including criteria is existed, only external spermatic vein is ligated at the depth of the inguinal canal and other veins are left alone for prevention of damage to the artery. Then another mini incision is made at high inguinal level and the rest of surgery is conducted by retroperitoneal approach. The incidence rate of major complications (recurrence, testicular atrophy, hydrocele) of experimental group is compared to the incidence rate of the same complications of the patients in control group that were operated with currently common inguinal and subinguinal microscopic varicocelectomy accompanied by testicular delivery, an approach that is suggested by Goldstein and associates. The study hypothesis is that using this method will lead to less major complications including recurrence, hydrocele and also less incidental injuries to the arteries that will result to less testicular atrophy.

Official Title
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Assessing Post-operative Rates of Recurrence, Hydrocele and Testicular Atrophy in Patients Operated With a New Approach of Varicocelectomy Named Combined Mini-incision Microscopic Varicocelectomy (CMMV)

Conditions
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Varicocele

Intervention / Treatment
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* Procedure: Combined Microscopic Varicocelectomy
* Procedure: Inguinal and Subinguinal varicocelectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complexity and tortuosity of the veins at inguinal level so that separating and ligation of the vein could lead to artery injury Veins which are contiguous with arteries so that separating and ligation of the vein could lead to artery injury Exclusion Criteria: Prior surgery at inguinal level such as Herniorrhaphy, Orchiopexy,etc.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined Microscopic Varicocelectomy<br>Patients in this arm were operated with Combined Mini-incision Microscopic approach | Procedure: Combined Microscopic Varicocelectomy<br>* After making a mini-incision at inguinal level, veins are evaluated, and if the including criteria (Complexity and tortuosity of the veins and/or existence of veins that are contiguous with arteries so that separating and ligation of the veins could jeopardize the artery) are existed, only external spermatic vein, if dilated, is ligated at the depth of the inguinal canal, and other veins are left alone for prevention of damage to the artery. Subsequently, another mini-incision is made at high inguinal level and the rest of surgery is conducted by retroperitoneal approach, which is also done microscopically<br>|
| Active Comparator: Inguinal and Subinguinal Varicocelectomy<br>Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associates | Procedure: Inguinal and Subinguinal varicocelectomy<br>* Microscopic Inguinal and Sub inguinal varicocelectomy, recommended by Goldstein and associates, are currently popular approaches. In this approach the spermatic cord structures are pulled up and out of the wound so that the testicular artery, lymphatics, and small periarterial veins may be more easily identified. In addition, an inguinal or subinguinal approach allows access to external spermatic and even gubernacular veins.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent Varicocele | post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-varicocelectomy Hydrocele | Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery | 6months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varicocele, varicocelectomy, complications of varicocelectomy, Recurrence of varicocele, Post-varicocelectomy testicular atrophy, Post-varicocelectomy hydrocele