Primary Prevention of Peristomial Hernias Via Parietal Prostheses: a Randomized, Multicentric Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 44
- Primary Endpoint
- Presence/absence of a peristomal hernia
Study Overview
Brief Summary
The purpose of this study is to compare rates of hernia formation between colostomies created with no hernia preventing mesh versus colostomies created with a particular mesh.
Detailed Description
Previous studies indicate that implanting mesh for peristomal hernia repair may efficiently prevent hernia relapse. However, mesh provides a good infection site, which is not a desirable characteristic for a material adjacent to a colostomy "port". Our goal is to implement a high-quality, randomized trial to demonstrate whether or not systematic mesh implantation upon primary hernia creation is an effective means of avoiding this common and troublesome complication.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patient has given informed consent
- •The patient must be affiliated with a health insurance programme
- •The patient must be available for 24 months of follow-up
- •The patient requires a colostomy (primo-event, ie first colostomies only)
Exclusion Criteria
- •The patient is currently participating in another interventional study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under guardianship
- •The patient refuses to sign the consent
- •It is impossible to communicate information to the patient (does not read French)
- •The patient is pregnant
- •The patient is breastfeeding
- •There is a contra-indication for any treatment used in this study
- •The subject has already had a colostomy
- •The subject has peritonitis
- •The subject needs a colostomy for infectious reasons
Outcomes
Primary Outcomes
Presence/absence of a peristomal hernia
Time Frame: 24 months
The occurrence of peristomal hernias is determined in both groups every three months up until 24 months. The presence of absence of a hernia is detected by clinical exam, and at 24 months by an additional radiology exam. The primary outcome concerns rates at 24 months, primo-events only.
Secondary Outcomes
- Operating time (minutes)(Day 1)
- Presence/absence of peristomal hernia(21 months)
- Days of hospitalisation(1 month)
- Estimation of blood loss during the operation (ml)(Day 1)
- Was stomal repair necessary for the patient? yes/no(24 months)
- Was relocation of the colostomy required? yes/no(24 months)
- Presence/absence of complications(21 months)
- Patient difficulty for fitting his/her colostomy with the appropriate sac.(21 months)
- Pain around the colostomy(21 months)
- Abdominal pain(21 months)
- Pain medication consumption(21 months)
- Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no(21 months)
- Number of colostomy leaks per day(21 months)
- Presence/absence of a complication potentially linked to the presence of a mesh?(24 months)
- Number of colostomy sac changes per day(21 months)
- Questionnaire Stoma-QOL(1 month)
- Exposition of the prothesis (mesh): yes/no(21 months)
- Presence/absence of peri-operative complications(Day 1)
- Ablation of the mesh: yes/no(24 months)
- Evaluation of colostomy healing by the clinician(24 months)
- Duration of postoperative fever (hours)(10 days)
- Presence/absence of postoperative fever > 37.2°C(Day 1)