Back to resultsIntraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis
Primary Purpose
Hernia, Umbilical
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Ventralex versus Leight Weight Vypro II prothesis
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Umbilical focused on measuring Hernia umbilicalis
Eligibility Criteria
Inclusion Criteria: Symptomatic hernia umbilicalis > 18 years old Exclusion Criteria: -
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ventralex
Leight Weight Vypro II prothesis
Arm Description
Outcomes
Primary Outcome Measures
Number of relapses after 1 and 3 years
Secondary Outcome Measures
Duration of surgery
Duration of hospitalisation
Frequency of complications
Pain assessment
Full Information
NCT ID
NCT00323141
First Posted
May 7, 2006
Last Updated
December 6, 2022
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00323141
Brief Title
Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 11, 2016 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Umbilical
Keywords
Hernia umbilicalis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ventralex
Arm Type
Active Comparator
Arm Title
Leight Weight Vypro II prothesis
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Ventralex versus Leight Weight Vypro II prothesis
Intervention Description
Ventralex and Leight Weight Vypro II prothesis are compared.
Primary Outcome Measure Information:
Title
Number of relapses after 1 and 3 years
Time Frame
after 1 and 3 years
Secondary Outcome Measure Information:
Title
Duration of surgery
Time Frame
Depends from type of surgery.
Title
Duration of hospitalisation
Time Frame
Depends from type of surgery.
Title
Frequency of complications
Time Frame
After 1 and 3 years.
Title
Pain assessment
Time Frame
After 1 and 3 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic hernia umbilicalis
> 18 years old
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Berrevoet, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis
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