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

December 11, 2007
January 25, 2011
February 2008
November 2010   (final data collection date for primary outcome measure)
recurrence rate [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00573105 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)
  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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ventral Hernia
  • Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh
    Laparoscopic Ventral hernia repair by heavy weight mesh
  • Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh
    Laparoscopic Ventral hernia repair by lighter weight mesh
  • Experimental: 1
    Laparoscopic Ventral hernia repair by heavy weight mesh
    Intervention: Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh
  • Experimental: 2
    Laparoscopic Ventral hernia repair by lighter weight mesh
    Intervention: Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
110
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00573105
2007/421
No
Frederik Berrevoet, University Hospital Ghent
University Hospital, Ghent
C. R. Bard
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
University Hospital, Ghent
January 2011

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