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
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: 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 August 19, 2014