Overview

This trial is active, not recruiting.

Condition hernia, inguinal
Treatments polysoft mesh, light weight mesh
Sponsor University Hospital, Ghent
Start date March 2006
End date August 2015
Trial size 50 participants
Trial identifier NCT00323674, 2006/080

Summary

This is a prospective randomized study to evaluate the recovery of a hernia inguinalis by a minimally invasive open preperitoneal surgery with polysoft mesh versus a classic open surgery according to modified Lichtenstein procedure with light weight mesh.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
light weight mesh
Light Weight Mesh is used.
(Active Comparator)
polysoft mesh
Polysoft Mesh is used.

Primary Outcomes

Measure
Percentage of relapse
time frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Postoperative pain assessment
time frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Duration to full recovery (able to do all activities)
time frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Symptomatic hernia inguinalis - > 18 years

Additional Information

Official title Prospective Randomized Study to Evaluate the Recovery of a Hernia Inguinalis by a Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery According to Modified Lichtenstein Procedure With Light Weight Mesh
Principal investigator Frederik Berrevoet, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.