Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: laparoscopic (TEP) inguinal hernia repair; Device: lightweight TiMesh; Device: lightweight VyproII; Device: Heavyweight Marlex

• Registration Number: NCT00925067
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

A randomized, prospective clinical trial analyzing whether the use of lightweight prostheses during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on postoperative discomfort, chronic pain development, recurrence and male fertility aspects.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2007-10
• Status Verified: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-18
• Last Update Submitted: 2009-06-18
• Study First Posted: 2009-06-19
• Last Update Posted: 2009-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 59

Inclusion Criteria

• Primary, unilateral or bilateral, inguinal hernia patients
• Informed consent

Exclusion Criteria

• Sterilized patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lightweight TiMesh	laparoscopic (TEP) inguinal hernia repair	-
lightweight TiMesh	lightweight TiMesh	-
lightweight VyproII	laparoscopic (TEP) inguinal hernia repair	-
lightweight VyproII	lightweight VyproII	-
Heavyweight Marlex	laparoscopic (TEP) inguinal hernia repair	-
Heavyweight Marlex	Heavyweight Marlex	-

Primary Outcome Measures

Name	Time	Method
Male fertility aspects	12 months

Secondary Outcome Measures

Name	Time	Method
Quality of life, pain development, recurrence	1, 3, 6 and 12 months

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium