Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair
Not Applicable
Completed
- Conditions
- Ventral Hernia
- Interventions
- Procedure: use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair
- Registration Number
- NCT00572962
- 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
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair
- Primary Outcome Measures
Name Time Method recurrence rate after 1 year
- Secondary Outcome Measures
Name Time Method morbidity rate perioperative postoperative pain within 1 week long term complication rate after 1 year quality of life after 1 year
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium