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

NCT ID: NCT07056868

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2028-10-31

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.

Conditions

Parastomal Hernia; Rectal Surgery; Stoma Complications; Extraperitoneal Stoma; Surgical Technique Comparison

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

extraperitoneal colostomy

Patients in this group will undergo extraperitoneal stoma creation using the arcuate line approach. This technique involves creating a stoma through the extraperitoneal space by accessing the posterior sheath at or below the arcuate line, thereby avoiding direct peritoneal entry. The goal is to reduce the risk of parastomal hernia by maintaining abdominal wall integrity and preventing intra-abdominal content herniation around the stoma.

Group Type: EXPERIMENTAL

extraperitoneal colostomy

Intervention Type: PROCEDURE

Patients in this group will undergo extraperitoneal stoma creation using the arcuate line approach. This technique involves creating a stoma through the extraperitoneal space by accessing the posterior sheath at or below the arcuate line, thereby avoiding direct peritoneal entry. The goal is to reduce the risk of parastomal hernia by maintaining abdominal wall integrity and preventing intra-abdominal content herniation around the stoma.

transperitoneal colostomy

Patients in this group will receive a conventional transperitoneal stoma. In this approach, the stoma is brought out through the abdominal wall via a peritoneal opening, which is the standard method used in colorectal surgery. This technique serves as the control for evaluating whether the arcuate line approach offers improved outcomes, particularly in reducing parastomal hernia incidence.

Group Type: ACTIVE_COMPARATOR

transperitoneal colostomy

Intervention Type: PROCEDURE

Patients in this group will receive a conventional transperitoneal stoma. In this approach, the stoma is brought out through the abdominal wall via a peritoneal opening, which is the standard method used in colorectal surgery. This technique serves as the control for evaluating whether the arcuate line approach offers improved outcomes, particularly in reducing parastomal hernia incidence.

Interventions

extraperitoneal colostomy

Patients in this group will undergo extraperitoneal stoma creation using the arcuate line approach. This technique involves creating a stoma through the extraperitoneal space by accessing the posterior sheath at or below the arcuate line, thereby avoiding direct peritoneal entry. The goal is to reduce the risk of parastomal hernia by maintaining abdominal wall integrity and preventing intra-abdominal content herniation around the stoma.

Intervention Type: PROCEDURE

transperitoneal colostomy

Patients in this group will receive a conventional transperitoneal stoma. In this approach, the stoma is brought out through the abdominal wall via a peritoneal opening, which is the standard method used in colorectal surgery. This technique serves as the control for evaluating whether the arcuate line approach offers improved outcomes, particularly in reducing parastomal hernia incidence.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

XIANG ZHANG

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xiang Zhang, M.D. Ph.D.

Role: CONTACT

xiang.zhang02@hotmail.com

+8618560089182

Yanlei Wang, M.D. Ph.D.

Role: CONTACT

+8618560085128

Other Identifiers

extraperitoneal colostomy

Identifier Type: -

Identifier Source: org_study_id