Prevention of Parastomal Hernia by Primary Mesh Insertion
Phase 2
Terminated
- Conditions
- Parastomal Hernia
- Registration Number
- NCT00641342
- Lead Sponsor
- University Hospital, Gentofte, Copenhagen
- Brief Summary
Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 198
Inclusion Criteria
- Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure.
Exclusion Criteria
- ASA > 3
- Acute surgery
- Known immune deficiency
- Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months.
- Pregnancy
- Known inflammatory bowel disease
- Lack of written informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Parastomal hernia verified by CT-scan one year after surgery, reassessed after 2, 3 and 5 years
- Secondary Outcome Measures
Name Time Method Clinically detected parastomal hernia one year after surgery, reassessed after 2, 3 and 5 years Disease specific and general health questionnaire one year after surgery, reassessed after 2, 3 and 5 years Pain one year after surgery, reassessed after 2, 3 and 5 years
Trial Locations
- Locations (2)
Copenhagen University Hospital, Hvidovre
🇩🇰Hvidovre, Copebhagen, Denmark
Copenhagen University Hospital, Gentofte
🇩🇰Hellerup, Copenhagen, Denmark
Copenhagen University Hospital, Hvidovre🇩🇰Hvidovre, Copebhagen, Denmark