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

Not Applicable

Not yet recruiting

• Conditions: Parastomal Hernia; Rectal Surgery; Stoma Complications; Extraperitoneal Stoma; Surgical Technique Comparison

• Registration Number: NCT07056868
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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.

Detailed Description

Parastomal hernia (PSH) is one of the most common long-term complications following stoma creation, with incidence rates reported as high as 30-50%. Conventional stoma formation typically uses a transperitoneal route, which may leave potential gaps in the abdominal wall through which herniation can occur.

Recent anatomical and surgical advances have proposed the arcuate line approach for extraperitoneal stoma creation, allowing the stoma to be tunneled outside the peritoneal cavity while preserving abdominal wall integrity. However, robust prospective evidence supporting its clinical benefits remains limited.

This randomized controlled trial will compare the arcuate line extraperitoneal approach with the traditional transperitoneal method, focusing on the incidence of parastomal hernia as the primary outcome. Secondary outcomes include postoperative complications, operative time, stoma function, and quality of life.

The results may provide high-level evidence to guide best practices in stoma surgery.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-29
• Study First Submitted QC: 2025-06-29
• Last Update Submitted: 2025-06-29
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09
• Study Start: 2025-08-01
• Primary Completion: 2028-08-01
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age 18-80 years
• Scheduled for laparoscopic abdominoperineal resection

Written informed consent

Exclusion Criteria

• Previous abdominal wall hernia

Emergency surgery

Severe comorbidities prohibiting safe surgery

Prior lower abdominal surgery affecting stoma site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Parastomal Hernia	36 months postoperatively	The occurrence of parastomal hernia will be assessed at 36 months after surgery through both clinical examination and abdominal CT imaging. Parastomal hernia will be defined based on radiological criteria (e.g., herniation of abdominal contents adjacent to the stoma) and/or physical examination findings (bulging or protrusion around the stoma site). The primary endpoint is the proportion of patients in each group who develop parastomal hernia within the follow-up period.