Use of a Mesh to Prevent Parastomal Hernia
Not Applicable
Completed
- Conditions
- Parastomal Hernia
- Interventions
- Device: Mesh (Ultrapro ®)Procedure: Conventional sigmoid end colostomy
- Registration Number
- NCT00691860
- Lead Sponsor
- Corporacion Parc Tauli
- Brief Summary
Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum,
- Aged over 18,
- Charlson comorbidity index below 7
- Elective surgery
- Radical surgery
Exclusion Criteria
- Loop colostomies,
- Emergency surgery,
- Body mass index above 35 kg/sq.m.,
- Palliative surgery,
- Hepatic cirrhosis,
- Severe COPD (requiring home oxygen treatment),
- Corticoid treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Conventional sigmoid end colostomy Patients receiving conventional sigmoid end colostomy plus a lightweight mesh Ultrapro® 2 Conventional sigmoid end colostomy Patients receiving conventional sigmoid end colostomy, without mesh 1 Mesh (Ultrapro ®) Patients receiving conventional sigmoid end colostomy plus a lightweight mesh Ultrapro®
- Primary Outcome Measures
Name Time Method the reduction in the incidence of Parastomal Hernia after the mesh placement 6 months
- Secondary Outcome Measures
Name Time Method