Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh

Not Applicable

Completed

• Conditions: Hernia, Inguinal
• Interventions: Device: Light Weight Mesh; Device: Polysoft Mesh

• Registration Number: NCT00323674
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-05-07
• Study First Submitted QC: 2006-05-07
• Study First Posted: 2006-05-09
• Primary Completion: 2015-08
• Study Completion: 2015-08-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

• Symptomatic hernia inguinalis
• > 18 years

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Light Weight Mesh	Light Weight Mesh	-
Polysoft Mesh	Polysoft Mesh	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium