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
- 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
- Primary Outcome Measures
Name Time Method recurrence rate after 1 year
- Secondary Outcome Measures
Name Time Method quality of life after 1 year morbidity rate perioperative postoperative pain within 1 week long term complication rate after 1 year
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which tissue separating mesh reduces recurrence in ventral hernia repair?
How does the Proceed® mesh compare to other synthetic meshes in laparoscopic ventral hernia repair outcomes?
Are there specific biomarkers that predict optimal patient selection for laparoscopic hernia repair with tissue separating mesh?
What are the potential adverse events associated with laparoscopic use of Proceed® mesh and their management strategies?
What combination approaches with Proceed® mesh have shown improved outcomes in ventral hernia repair compared to standalone use?
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium
University Hospital Ghent🇧🇪Ghent, Belgium