None listed
Conditions
Brief summary
This is a prospective, single-blind, randomised, parallel-group, controlled proof-of-concept study to evaluate the safety and efficacy of the implantation of a prophylactic mesh at the time of the formation of a permanent stoma, compared to standard stoma formation, at preventing the incidence of herniae formation or the risk of stoma and non-stoma related complications.
Interventions
Mesh Intervention Procedure:
Subjects in this arm of the study will have mesh permanently implanted at the stoma site at the time of their surgery. The procedure duration will differ between patients depending on the circumstances of, and indications for, the surgery. The stoma formation will be performed as follows:
1. Dissect away a section of peritoneum and posterior rectus sheath on the side of the colostomy from the posterior aspect of the rectus abdominus muscle with the centre of the supe
Mesh Intervention Procedure: Subjects in this arm of the study will have mesh permanently implanted at the stoma site at the time of their surgery. The procedure duration will differ between patients depending on the circumstances of, and indications for, the surgery. The stoma formation will be performed as follows: 1. Dissect away a section of peritoneum and posterior rectus sheath on the side of the colostomy from the posterior aspect of the rectus abdominus muscle with the centre of the superior-inferior aspect of this area at the level of the marked colostomy trephine site. 2. Place a piece of 15cm x 15cm mesh in the space. 3. Secure the lateral corners of the mesh to the lateral abdominal wall musculature with a permanent suture. 4. Make the trephine at the marked site using a circular skin incision and deepen through abdominal wall fat to the fascia. Make a cruciate incision in the anterior rectus sheath, split the rectus abdominus muscle longitudinally. 5. Cut a circle in the centre of the mesh and the peritoneum of a size just adequate to allow easy passage of the colon through the mesh and then the abdominal wall. 6. Deliver the colon through the trephine site to the skin. 7. Close fascia. 8. Irrigate wound. 9. Close the midline wound skin. 10. Apply a dressing to the midline wound. 11. Mature the colostomy using dissolvable sutures. 12. Apply the colostomy bag.
Sponsors
The Lyell McEwin Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Subjects requiring elective admission for an open colon or colorectal resection to include the formation of a permanent end colostomy. The procedures will include the following: a. Abdomino-perineal resection of the rectum; b. Rectosigmoidectomy (Hartmann’s procedure); or c. Formation of end colostomy for incontinence.
Exclusion criteria
1. Subjects who do not consent to participate in the trial or are unable to provide informed consent. This may include patients who are not able to understand or follow the trial protocol because English is not their first language, or because of medical or psychiatric conditions. 2. Subjects who are having emergency operations. 3. Subjects with grossly disseminated disease, who are not expected to live longer than 12 months. 4. Subjects in whom there is significant spillage of faecal contents in the area of the wound or the stoma site during the procedure. 5. Subjects with inflammatory bowel disease, including Crohn's disease or irritable bowel syndrome. 6. Subjects with concurrent infection at the operating site or the stoma site at the time of the surgery. 7. Females who are pregnant or breastfeeding.
Outcome results
None listed