Parastomal Hernia Prevention Trial

ABSTRACT: 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 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. Primary outcome(s): The formation of clinically-apparent parastomal herniae. Assessment: Clinical assessment of stoma site.[6 weeks and 6, 12, 36 and 120 months postoperatively.];The formation of radiologically-apparent parastomal herniae. Assessment: CT scan of abdomen[12, 36 and 120 months postoperatively.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Surgery-other Surgery,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Permanant Colostomy,Parastomal Hernia

PROVIDER: 2457689 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR