- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00323141
Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis
December 6, 2022 updated by: University Hospital, Ghent
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
To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ghent, Belgium, 9000
- University Hospital Ghent
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Symptomatic hernia umbilicalis
- > 18 years old
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ventralex
|
Ventralex and Leight Weight Vypro II prothesis are compared.
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Active Comparator: Leight Weight Vypro II prothesis
|
Ventralex and Leight Weight Vypro II prothesis are compared.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of relapses after 1 and 3 years
Time Frame: after 1 and 3 years
|
after 1 and 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of surgery
Time Frame: Depends from type of surgery.
|
Depends from type of surgery.
|
Duration of hospitalisation
Time Frame: Depends from type of surgery.
|
Depends from type of surgery.
|
Frequency of complications
Time Frame: After 1 and 3 years.
|
After 1 and 3 years.
|
Pain assessment
Time Frame: After 1 and 3 years.
|
After 1 and 3 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2016
Primary Completion (Actual)
August 31, 2017
Study Completion (Actual)
August 31, 2017
Study Registration Dates
First Submitted
May 7, 2006
First Submitted That Met QC Criteria
May 7, 2006
First Posted (Estimate)
May 9, 2006
Study Record Updates
Last Update Posted (Estimate)
December 7, 2022
Last Update Submitted That Met QC Criteria
December 6, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006/079
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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