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

Not Applicable

Completed

• Conditions: Varicocele

• Registration Number: NCT02092311
• Lead Sponsor: Omid Fertility Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2013-09
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-20
• Results First Submitted: 2014-04-10
• Results First Submitted QC: 2014-05-28
• Results First Posted: 2014-06-30
• Status Verified: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-07
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 570

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrent Varicocele	6 months	post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery

Secondary Outcome Measures

Name	Time	Method
Post-varicocelectomy Hydrocele	6months	Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery

Trial Locations

Locations (1)

Omid fertility center; 🇮🇷 Tehran, Iran, Islamic Republic of