Single Incision Laparoscopic Varicocelectomy

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT02335385

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

Conventional laparoscopic varicocelectomy using 3 ports has been used for treatment of varicocele in our department since the nineties. However, the relatively several trocar wounds represent a big challenge against its acceptance by many of our patients who prefer the open approach with one or at least two wounds.

Single incision laparoscopic surgery (SILS), since its introduction in 2007, has been proven to be feasible and effective, with high patient satisfaction rates regarding improved cosmotic outcomes, reduced postoperative pain, and rapid return to normal activities. (10, 11) SILS for varicocelectomy has been reported to be safe and effective alternative to conventional laparoscopic varicocelectomy in a few studies.

Condition or Disease	Intervention/Treatment	Phase
Varicocele	Procedure: single incision laparoscopic varicocelectomy Procedure: conventional transperitoneal laparoscopic varicocelectomy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Single Incision Transumbilical Laparoscopic Varicocelectomy: Comparison With the Conventional Laparoscopic Approach.

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SIL-V single incision laparoscopic varicocelectomy	Procedure: single incision laparoscopic varicocelectomy bilateral and unilateral varicocelectomy was performed through a single transumbilical flexible SILS port.
Active Comparator: CTL-V conventional transperitoneal laparoscopic varicocelectomy	Procedure: conventional transperitoneal laparoscopic varicocelectomy bilateral and unilateral varicocelectomy was performed through a conventional 3-ports transperitoneal varicoceletomy

Arm

Intervention/Treatment

Active Comparator: SIL-V

single incision laparoscopic varicocelectomy

Procedure: single incision laparoscopic varicocelectomy

bilateral and unilateral varicocelectomy was performed through a single transumbilical flexible SILS port.

Active Comparator: CTL-V

conventional transperitoneal laparoscopic varicocelectomy

Procedure: conventional transperitoneal laparoscopic varicocelectomy

bilateral and unilateral varicocelectomy was performed through a conventional 3-ports transperitoneal varicoceletomy

Outcome Measures

Primary Outcome Measures

number of patients with improvement in semen parameters and resolution of testicular pain [2 years]

Secondary Outcome Measures

number of patients developing postoperative complications [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with palpable varicoceles

Exclusion Criteria:

unfit for anesthesia or laparoscopy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tamer Youssef Mohamed, assistant professor of surgery, Mansoura University

ClinicalTrials.gov Identifier:

NCT02335385

Other Study ID Numbers:

MFM200912

First Posted:

Jan 9, 2015

Last Update Posted:

Jan 9, 2015

Last Verified:

Jan 1, 2015

Additional relevant MeSH terms:

Varicocele

Study Results

No Results Posted as of Jan 9, 2015