Prevention of Umbilical Port-site Hernia After Laparoscopic Cholecystectomy Using a Prosthetic Mesh Versus Simple Suture
Phase 3
Completed
- Conditions
- Port-site Hernia
- Interventions
- Procedure: Fascial sutureProcedure: Prophylactic mesh placement
- Registration Number
- NCT01802229
- Lead Sponsor
- Hospital General Universitario Elche
- Brief Summary
The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of umbilical port site.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
Inclusion Criteria
- Age > 65 years
- BMI > 30 Kg/m2
- Diabetes mellitus
- Lung disease
- Elective laparoscopic cholecystectomy
Exclusion Criteria
- Umbilical hernia
- Previous laparotomy
- Conversion to open procedure
- Loss during the follow up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Suture Fascial suture Umbilical port-site closure with simple suture of the fascia. Prophylactic mesh Prophylactic mesh placement Umbilical port-site closure with mesh placement
- Primary Outcome Measures
Name Time Method Incidence of port-site hernia 12 months Comparison of incidence of port-site hernia between patiensts with and without prophylactic mesh placement
- Secondary Outcome Measures
Name Time Method Postoperative pain 12 months Evaluation of different pain perception in patients with and without prophylactic mesh placement, determined in the postoperative course and at 1, 6 and 12 months after surgery
Trial Locations
- Locations (1)
Hospital general Universitario de Elche
🇪🇸Elche, Alicante, Spain