Single Incision Laparoscopic Varicocelectomy

January 7, 2015 updated by: Tamer Youssef Mohamed, Mansoura University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • patients with palpable varicoceles

Exclusion Criteria:

  • unfit for anesthesia or laparoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of patients with improvement in semen parameters and resolution of testicular pain
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
number of patients developing postoperative complications
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

January 7, 2015

First Posted (ESTIMATE)

January 9, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFM200912

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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