Intraperitoneal Mesh-Implementation After Laparotomy
Not Applicable
- Conditions
- Incisional Hernia
- Interventions
- Device: Mesh implementation
- Registration Number
- NCT01003067
- Lead Sponsor
- Kantonsspital Liestal
- Brief Summary
Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation after laparotomy (Group 1) in a randomized control trial compared with patients with standard abdominal closure (Everett-suture). This is the primary endpoint. Second endpoints are the feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound infection and incisional hernia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 267
Inclusion Criteria
- Informed consent
- Median Laparotomy
Exclusion Criteria
- Bowel perforation
- Pregnancy
- Palliative surgery
- Drug abuse
- Age under 18
- Mental disability
- Allergy to mesh components
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mesh Implementation Mesh implementation -
- Primary Outcome Measures
Name Time Method Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy 2 years Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.
- Secondary Outcome Measures
Name Time Method Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia. 5 Years Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.
Trial Locations
- Locations (1)
Kantonsspital Liestal
🇨🇭Liestal, BL, Switzerland