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