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

Varicocele Clinical Trial

— CMMV  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092311
• Other study ID #: CMMV
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: June 7, 2015
• Start date: January 2006
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Omid Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Shahid Beheshti University of Medical SciencesIran: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: June 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicocele

Intervention

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
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Omid fertility center	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Omid Fertility Center	hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-varicocelectomy Testicular Atrophy	development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery	6months	Yes
Primary	Recurrent Varicocele	post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery	6 months	Yes
Secondary	Post-varicocelectomy Hydrocele	Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery	6months	Yes