Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Primary Endpoint
- the reduction in the incidence of Parastomal Hernia after the mesh placement
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
the reduction in the incidence of Parastomal Hernia after the mesh placement
Time Frame: 6 months
Secondary Outcomes
No secondary outcomes reported