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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary:

  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

Detailed Summary:
Sponsor: University Hospital, Ghent

Current Primary Outcome: recurrence rate [ Time Frame: after 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • morbidity rate [ Time Frame: perioperative ]
  • quality of life [ Time Frame: after 1 year ]
  • postoperative pain [ Time Frame: within 1 week ]
  • long term complication rate [ Time Frame: after 1 year ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Ghent

Dates:
Date Received: December 11, 2007
Date Started: February 2008
Date Completion:
Last Updated: January 25, 2011
Last Verified: January 2011