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

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)

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

Study Overview

• Status: Completed
• Conditions: Varicocele
• Intervention / Treatment: Procedure: Combined Microscopic Varicocelectomy; Procedure: Inguinal and Subinguinal varicocelectomy

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 Type: Interventional
• Enrollment (Actual): 570
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Omid fertility center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined Microscopic Varicocelectomy; Patients in this arm were operated with Combined Mini-incision Microscopic approach	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
Active Comparator: Inguinal and Subinguinal Varicocelectomy; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-varicocelectomy Testicular Atrophy	development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery	6months

Collaborators and Investigators

• Sponsor: Omid Fertility Center
• Collaborators: Shahid Beheshti University of Medical Sciences
• Investigators: Study Director: Omid Pouyan, MD, Omid fertility center; Principal Investigator: Navid Pooyan, MD, Omid fertility center; Study Chair: Robabeh Taheri Panah, MD, Infertility and Reproductive Health research center of Shahid Beheshti university of medical sciences; Study Chair: Ashraf Ale Yasin, MD, Omid fertility center; Study Chair: Marzieh Agha Hosseini, MD, Omid fertility center; Study Chair: Hojatollah Saeidi Saeid Abadi, P.H.D, Omid FC

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 18, 2014
• First Posted (Estimate): March 20, 2014

Study Record Updates

• Last Update Posted (Estimate): July 3, 2015
• Last Update Submitted That Met QC Criteria: June 7, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: varicocele; varicocelectomy; complications of varicocelectomy; Recurrence of varicocele; Post-varicocelectomy testicular atrophy; Post-varicocelectomy hydrocele
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicocele
• Other Study ID Numbers: CMMV