Overview
The aim of this study is to evaluate safety and effectiveness of a hybrid mesh (GORE® SYNECOR Intraperitoneal Biomaterial) in patients with a BMI of 30 kg/m2 or more undergoing laparoscopic ventral hernia repair (LVHR) with intraperitoneal position of the mesh.
Description
A prospective Italian multicenter observational trial will be conducted in 8 different Italian centers to compare the effectiveness and feasibility of treatment of Incisional Hernia with GORE® SYNECOR Intraperitoneal Biomaterial mesh in patients with BMI >30 kg/m2. This study was reviewed and approved by the local regional Ethics Committee. The study adhered to the CONSORT guidelines in reporting this trial's results
Eligibility
Inclusion Criteria:
- age > 18 years
- Clean wounds
- Informed consent
- Patients affected by Incisional and Ventral Hernia
- Elective surgery
- Hernia size between 3 e 7 cm
- BMI > 30 kg/m2
Exclusion Criteria:
- age < 18 years;
- Life expectancy < 24 months (as estimated by the operating surgeon), -
- Pregnancy
- Immunosuppressant therapy within 2 weeks before surgery
- Clean-contaminated and contaminated, dirty wounds
- Cirrhosis