Single Incision Laparoscopic Varicocelectomy

Varicocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335385
• Other study ID #: MFM200912
• Status: Completed
• Phase: N/A
• First received: January 7, 2015
• Last updated: January 7, 2015
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: January 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Mansoura Faculty of medicin
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with palpable varicoceles

Exclusion Criteria:

• unfit for anesthesia or laparoscopy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicocele

Intervention

Procedure:
• single incision laparoscopic varicocelectomy
bilateral and unilateral varicocelectomy was performed through a single transumbilical flexible SILS port.
• conventional transperitoneal laparoscopic varicocelectomy
bilateral and unilateral varicocelectomy was performed through a conventional 3-ports transperitoneal varicoceletomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with improvement in semen parameters and resolution of testicular pain		2 years	Yes
Secondary	number of patients developing postoperative complications		2 years	Yes