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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

Tracking Information
First Submitted Date  ICMJE May 7, 2006
First Posted Date  ICMJE May 9, 2006
Last Update Posted Date December 5, 2014
Study Start Date  ICMJE March 2006
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2011)
Number of relapses after 1 and 3 years [ Time Frame: after 1 and 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2006)
Number of relapses after 1 and 3 years
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2011)
  • Duration of surgery [ Time Frame: Depends from type of surgery. ]
  • Duration of hospitalisation [ Time Frame: Depends from type of surgery. ]
  • Frequency of complications [ Time Frame: After 1 and 3 years. ]
  • Pain assessment [ Time Frame: After 1 and 3 years. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2006)
  • Duration of surgery
  • Duration of hospitalisation
  • Frequency of complications
  • Pain assessment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis
Official Title  ICMJE 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
Brief Summary To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hernia, Umbilical
Intervention  ICMJE Device: Ventralex versus Leight Weight Vypro II prothesis
Ventralex and Leight Weight Vypro II prothesis are compared.
Study Arms  ICMJE
  • Active Comparator: Ventralex
    Intervention: Device: Ventralex versus Leight Weight Vypro II prothesis
  • Active Comparator: Leight Weight Vypro II prothesis
    Intervention: Device: Ventralex versus Leight Weight Vypro II prothesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 7, 2006)
50
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2015
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Symptomatic hernia umbilicalis
  • > 18 years old

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00323141
Other Study ID Numbers  ICMJE 2006/079
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frederik Berrevoet, MD, PhD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP