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

NCT ID: NCT02092311

Last Updated: 2015-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 570 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2015-06-30

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.

Conditions

Varicocele

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined Microscopic Varicocelectomy

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

Group Type: EXPERIMENTAL

Combined Microscopic Varicocelectomy

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

Inguinal and Subinguinal varicocelectomy

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: collaborator

Omid Fertility Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Omid Pouyan, MD

Role: STUDY_DIRECTOR

Omid Fertility Center

Navid Pooyan, MD

Role: PRINCIPAL_INVESTIGATOR

Omid Fertility Center

Robabeh Taheri Panah, MD

Role: STUDY_CHAIR

Infertility and Reproductive Health research center of Shahid Beheshti university of medical sciences

Ashraf Ale Yasin, MD

Role: STUDY_CHAIR

Omid Fertility Center

Marzieh Agha Hosseini, MD

Role: STUDY_CHAIR

Omid Fertility Center

Hojatollah Saeidi Saeid Abadi, P.H.D

Role: STUDY_CHAIR

Omid FC

Locations

Omid fertility center

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

CMMV

Identifier Type: -

Identifier Source: org_study_id