Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis

Not Applicable

Completed

• Conditions: Hernia, Umbilical
• Interventions: Device: Ventralex versus Leight Weight Vypro II prothesis

• Registration Number: NCT00323141
• Lead Sponsor: University Hospital, Ghent

Brief Summary

To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-07
• Study First Submitted QC: 2006-05-07
• Study First Posted: 2006-05-09
• Study Start: 2016-03-11
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Symptomatic hernia umbilicalis
• > 18 years old

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leight Weight Vypro II prothesis	Ventralex versus Leight Weight Vypro II prothesis	-
Ventralex	Ventralex versus Leight Weight Vypro II prothesis	-

Primary Outcome Measures

Name	Time	Method
Number of relapses after 1 and 3 years	after 1 and 3 years

Secondary Outcome Measures

Name	Time	Method
Duration of surgery	Depends from type of surgery.
Duration of hospitalisation	Depends from type of surgery.
Pain assessment	After 1 and 3 years.
Frequency of complications	After 1 and 3 years.

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium