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Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis
This study is currently recruiting participants.
Verified by University Hospital, Ghent, December 2007
Sponsored by: University Hospital, Ghent
Information provided by: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00323141
  Purpose

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


Condition Intervention
Hernia, Umbilical
Device: Ventralex versus Leight Weight Vypro II prothesis

MedlinePlus related topics: Hernia
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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

Further study details as provided by University Hospital, Ghent:

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

Estimated Enrollment: 50
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic hernia umbilicalis
  • > 18 years old

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323141

Contacts
Contact: Frederik Berrevoet, MD 0032/(0)9/240.48.92 frederik.berrevoet@UGent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Frederik Berrevoet, MD     0032/(0)9/240.48.92     frederik.berrevoet@UGent.be    
Principal Investigator: Frederik Berrevoet, MD            
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
  More Information

Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

Study ID Numbers: 2006/079
Study First Received: May 7, 2006
Last Updated: December 19, 2007
ClinicalTrials.gov Identifier: NCT00323141  
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Hernia umbilicalis

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal
Hernia, Umbilical
Hernia, Ventral
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on January 14, 2009