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Clinical Trials/NCT00323141
NCT00323141CompletedNot Applicable

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

University Hospital, Ghent1 site in 1 country50 target enrollmentStarted: March 11, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Number of relapses after 1 and 3 years
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Symptomatic hernia umbilicalis
  • •> 18 years old

Exclusion Criteria

  • Not provided

Arms & Interventions

Leight Weight Vypro II prothesis

Active Comparator

Intervention: Ventralex versus Leight Weight Vypro II prothesis (Device)

Ventralex

Active Comparator

Intervention: Ventralex versus Leight Weight Vypro II prothesis (Device)

Outcomes

Primary Outcomes

Number of relapses after 1 and 3 years

Time Frame: after 1 and 3 years

Secondary Outcomes

  • Frequency of complications(After 1 and 3 years.)
  • Duration of surgery(Depends from type of surgery.)
  • Duration of hospitalisation(Depends from type of surgery.)
  • Pain assessment(After 1 and 3 years.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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