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Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis

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ClinicalTrials.gov Identifier: NCT00323141
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Active, not recruiting
First Posted : May 9, 2006
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

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

Condition or disease Intervention/treatment
Hernia, Umbilical Device: Ventralex versus Leight Weight Vypro II prothesis

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2006
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Ventralex Device: Ventralex versus Leight Weight Vypro II prothesis
Ventralex and Leight Weight Vypro II prothesis are compared.
Active Comparator: Leight Weight Vypro II prothesis Device: Ventralex versus Leight Weight Vypro II prothesis
Ventralex and Leight Weight Vypro II prothesis are compared.



Primary Outcome Measures :
  1. Number of relapses after 1 and 3 years [ Time Frame: after 1 and 3 years ]

Secondary Outcome Measures :
  1. Duration of surgery [ Time Frame: Depends from type of surgery. ]
  2. Duration of hospitalisation [ Time Frame: Depends from type of surgery. ]
  3. Frequency of complications [ Time Frame: After 1 and 3 years. ]
  4. Pain assessment [ Time Frame: After 1 and 3 years. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic hernia umbilicalis
  • > 18 years old

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323141


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Frederik Berrevoet, MD, PhD University Hospital, Ghent

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00323141     History of Changes
Other Study ID Numbers: 2006/079
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
Hernia umbilicalis

Additional relevant MeSH terms:
Hernia
Hernia, Umbilical
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal