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

Omid Fertility Center

Status: Completed

Conditions: Varicocele

Treatments: Procedure: Inguinal and Subinguinal varicocelectomy; Procedure: Combined Microscopic Varicocelectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02092311

CMMV

Details and patient eligibility

About

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

Full 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.

Enrollment: 570 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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570 participants in 2 patient groups

Combined Microscopic Varicocelectomy

Experimental group

Description:

Patients in this arm were operated with Combined Mini-incision Microscopic approach

Treatment:

Procedure: Combined Microscopic Varicocelectomy

Inguinal and Subinguinal Varicocelectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Inguinal and Subinguinal varicocelectomy