Parastomal Hernia Prevention Trial

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2011
INTERVENTION: 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. CONDITION: Parastomal Hernia Permanant colostomy PRIMARY OUTCOME: The formation of clinically‐apparent parastomal herniae. ; Assessment: ; Clinical assessment of stoma site. The formation of radiologically‐apparent parastomal herniae. ; Assessment: ; CT scan of abdomen SECONDARY OUTCOME: All cause mortality ; Assessment: ; 1. Medical record review Complications, including stomal stricture, stoma dehiscence, wound dehiscence, stomal fistula, small bowel obstruction, wound infection, pelvic abscess, or incisional hernia. ; Assessment: ; 1. Clinical assessment ; 2. X‐ray(where necessary to confirm diagnosis) ; 3. Blood tests (where necessary to confirm diagnosis) Duration of hospital length of stay. ; Assessment: ; Number of days from time of surgery until discharge from hospital. Duration of operating time. ; Assessments: ; 1. Duration between knife‐to‐skin and last suture. ; 2. Duration between commencing stoma formation and attachment of colostomy bag. New or recurrent malignancy. ; Assessment: ; 1. Clinical assessment ; 2. CT scan (where necessary to confirm diagnosis) ; 3. Blood tests (where necessary to confirm diagnosis) Re‐operation. ; Assessment: ; 1. Medical record review Readmission to hospital. ; Assessment: ; 1. Medical record review 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.
Epistemonikos ID: 25294ee8b1f53691d7d06d6aa4b7deb69efdb7ec
First added on: Aug 22, 2024