Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)
Not Applicable
Terminated
- Conditions
- Ventral Hernia
- Interventions
- Procedure: Laparoscopic Ventral hernia repair by lighter weight meshProcedure: Laparoscopic Ventral hernia repair by heavy weight mesh
- Registration Number
- NCT00573105
- Lead Sponsor
- University Hospital, Ghent
- 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 Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 110
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Laparoscopic Ventral hernia repair by lighter weight mesh Laparoscopic Ventral hernia repair by lighter weight mesh 1 Laparoscopic Ventral hernia repair by heavy weight mesh Laparoscopic Ventral hernia repair by heavy weight mesh
- Primary Outcome Measures
Name Time Method recurrence rate after 1 year
- Secondary Outcome Measures
Name Time Method morbidity rate perioperative quality of life after 1 year postoperative pain within 1 week long term complication rate after 1 year
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium