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

NCT00925067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2009-06-19

No results posted yet for this study

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.

Conditions

  • Inguinal Hernia

Interventions

PROCEDURE

laparoscopic (TEP) inguinal hernia repair

laparoscopic inguinal hernia repair with a standard heavyweight Marlex (control group) prosthesis or new generation lightweight VyproII and TiMesh prostheses (study group)

DEVICE

lightweight TiMesh

DEVICE

lightweight VyproII

DEVICE

Heavyweight Marlex

Sponsors & Collaborators

  • Fund for Scientific Research, Flanders, Belgium

    collaborator OTHER

  • Agentschap voor Innovatie door Wetenschap en Technologie

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Marc Miserez, MD, PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2007-10-31
Completion
2009-06-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00925067 on ClinicalTrials.gov