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

NCT02092311 | Completed Results

• 1 other identifier: CMMV
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

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

Conditions

Varicocele

Keywords

varicocele; varicocelectomy; complications of varicocelectomy; Recurrence of varicocele; Post-varicocelectomy testicular atrophy; Post-varicocelectomy hydrocele

Outcome Measures

Primary Outcomes (1)

• Recurrent Varicocele

  post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery

  6 months

Secondary Outcomes (1)

• Post-varicocelectomy Hydrocele

  6months

Other Outcomes (1)

• Post-varicocelectomy Testicular Atrophy

  6months

Study Arms (2)

Combined Microscopic Varicocelectomy

EXPERIMENTAL

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

Procedure: Combined Microscopic Varicocelectomy

Inguinal and Subinguinal Varicocelectomy

ACTIVE COMPARATOR

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

Interventions

Combined Microscopic Varicocelectomy 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

Combined Microscopic Varicocelectomy

Inguinal and Subinguinal varicocelectomy 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.

Inguinal and Subinguinal Varicocelectomy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior surgery at inguinal level such as Herniorrhaphy, Orchiopexy,etc.

Sponsors & Collaborators

• Omid Fertility Center: lead
• Shahid Beheshti University of Medical Sciences: collaborator

Study Sites (1)

Omid fertility center

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr.Navid Pooyan
• Organization: OMID FERTILITY CENTER

navidpooyan@yahoo.com

00989124474032

Study Officials

• Omid Pouyan, MD

  Omid Fertility Center

  STUDY DIRECTOR

• Navid Pooyan, MD

  Omid Fertility Center

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 20, 2014
• Study Start: January 1, 2006
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2015
• Last Updated: July 3, 2015
• Results First Posted: June 30, 2014

Record last verified: 2015-06

Locations

IR (1)