Clinical Trial

A Prospective Randomized Controlled Trial Comparing Extraperitoneal Stoma Creation Via the Arcuate Line Approach Versus Conventional Transperitoneal Stoma Formation for the Prevention of Parastomal Hernia

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Summary
This study is a prospective, randomized controlled trial designed to compare two surgical techniques for stoma creation in patients undergoing colorectal surgery. The trial evaluates whether an extraperitoneal stoma created via the arcuate line approach can reduce the risk of developing parastomal hernia compared to the conventional transperitoneal stoma formation. Parastomal hernia is a common complication after stoma surgery, often requiring additional treatment or surgery. By testing a novel surgical route that avoids entering the abdominal cavity, this study aims to improve postoperative outcomes and quality of life for patients requiring a permanent stoma.
Trial Details
NCT Number NCT07056868
Lead Sponsor Qilu Hospital of Shandong University
Conditions Parastomal Hernia, Rectal Surgery, Stoma Complications, Extraperitoneal Stoma, Surgical Technique Comparison
Enrollment 200 participants
Start Date 2025-08-01
Primary Completion 2028-08-01 (estimated)
Study Completion 2028-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-09