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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00323141
First received: May 7, 2006
Last updated: February 1, 2013
Last verified: February 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Number of relapses after 1 and 3 years [ Time Frame: after 1 and 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of surgery [ Time Frame: Depends from type of surgery. ] [ Designated as safety issue: No ]
  • Duration of hospitalisation [ Time Frame: Depends from type of surgery. ] [ Designated as safety issue: No ]
  • Frequency of complications [ Time Frame: After 1 and 3 years. ] [ Designated as safety issue: No ]
  • Pain assessment [ Time Frame: After 1 and 3 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2006
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00323141     History of Changes
Other Study ID Numbers: 2006/079
Study First Received: May 7, 2006
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014