Circular stapled end colostomy versus conventional end colostomy creation in patients undergoing a permanent stoma: a randomized controlled trial.

Background: Parastomal herniation is a prevalent complication of colostomies, with rates as high as 60% at 2 years. Traditional methods, including mesh use, have shown limited success. Here, we aim to compare 1-year PSH rates and evaluate stoma-related complications using a stapled versus conventional approach.

Methods: This randomized controlled trial investigates the efficacy of using a circular stapler to create an end colostomy for reducing parastomal hernia (PSH) incidence compared to conventional techniques. Eligible patients (aged 18-70) undergoing end colostomy for rectal cancer at Tata Memorial Hospital will be randomized into two groups: circular stapled versus conventional cruciate incision. Primary outcomes will be 1-year PSH rates, determined clinically and radiologically, with secondary outcomes including short-term stoma-related complications and reoperation rates.

Discussion: The study's findings will provide evidence on the circular stapler's effectiveness in reducing PSH incidence, potentially offering an innovative approach to ostomy creation. If successful, this technique may improve patient outcomes and reduce long-term healthcare costs related to PSH management. Trial registration CTRI/2023/10/059362; protocol version 1.2. Registered on March 11, 2023.