NCT02092311

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 570 (actual)
• Sponsor: Omid Fertility Center · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Varicocele

Interventions

Type	Name	Description
PROCEDURE	Combined Microscopic Varicocelectomy	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
PROCEDURE	Inguinal and Subinguinal varicocelectomy	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.

Timeline

• Start date: 2006-01-01
• Primary completion: 2013-09-01
• Completion: 2015-06-01
• First posted: 2014-03-20
• Last updated: 2015-07-03
• Results posted: 2014-06-30

Locations

1 site across 1 country: Iran