Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)

This study has been terminated.
(slow inclusion rate)
Sponsor:
Collaborator:
C. R. Bard
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00573105
First received: December 11, 2007
Last updated: January 25, 2011
Last verified: January 2011
  Purpose
  1. General

    - antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery

  2. Laparoscopic surgery

    • at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)
    • with or without anchoring transparietal sutures or double crown technique

Condition Intervention
Ventral Hernia
Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh
Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • recurrence rate [ Time Frame: after 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • morbidity rate [ Time Frame: perioperative ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
  • postoperative pain [ Time Frame: within 1 week ] [ Designated as safety issue: No ]
  • long term complication rate [ Time Frame: after 1 year ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: February 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Laparoscopic Ventral hernia repair by heavy weight mesh
Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh
Laparoscopic Ventral hernia repair by heavy weight mesh
Experimental: 2
Laparoscopic Ventral hernia repair by lighter weight mesh
Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh
Laparoscopic Ventral hernia repair by lighter weight mesh

  Eligibility

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

Inclusion Criteria:

  • written informed consent from the patient or his/her legal representative
  • ventral hernia requiring elective surgical repair

Exclusion Criteria:

  • no written informed consent
  • 'hostile' abdomen; open abdomen treatment
  • contraindication to pneumoperitoneum
  • emergency surgery (incarcerated hernia)
  • parastomal hernia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573105

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
C. R. Bard
Investigators
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: Frederik Berrevoet, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00573105     History of Changes
Other Study ID Numbers: 2007/421
Study First Received: December 11, 2007
Last Updated: January 25, 2011
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 22, 2014