Overview

This trial is active, not recruiting.

Condition hernia, umbilical
Treatment ventralex versus leight weight vypro ii prothesis
Sponsor University Hospital, Ghent
Start date March 2006
End date August 2015
Trial size 50 participants
Trial identifier NCT00323141, 2006/079

Summary

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

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)
ventralex versus leight weight vypro ii prothesis
Ventralex and Leight Weight Vypro II prothesis are compared.
(Active Comparator)
ventralex versus leight weight vypro ii prothesis
Ventralex and Leight Weight Vypro II prothesis are compared.

Primary Outcomes

Measure
Number of relapses after 1 and 3 years
time frame: after 1 and 3 years

Secondary Outcomes

Measure
Duration of surgery
time frame: Depends from type of surgery.
Duration of hospitalisation
time frame: Depends from type of surgery.
Frequency of complications
time frame: After 1 and 3 years.
Pain assessment
time frame: After 1 and 3 years.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Symptomatic hernia umbilicalis - > 18 years old Exclusion Criteria: -

Additional Information

Official title Prospective Randomized Trial to Study the Effectiveness of an Intraperitoneal Mesh With an Overlap of 3cm Versus a Rives-Stoppa Repair With an Overlap of 6cm With Patients With a Hernia Umbilicalis
Principal investigator Frederik Berrevoet, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.