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

NCT07056868 | Not Yet Recruiting

• 1 other identifier: extraperitoneal colostomy
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Parastomal Hernia

  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.

  36 months postoperatively

Study Arms (2)

extraperitoneal colostomy

EXPERIMENTAL

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.

Procedure: extraperitoneal colostomy

transperitoneal colostomy

ACTIVE COMPARATOR

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.

Procedure: transperitoneal colostomy

Interventions

extraperitoneal colostomy 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.

extraperitoneal colostomy

transperitoneal colostomy 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.

transperitoneal colostomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• Scheduled for laparoscopic abdominoperineal resection
• Written informed consent

You may not qualify if:

• Previous abdominal wall hernia
• Emergency surgery
• Severe comorbidities prohibiting safe surgery
• Prior lower abdominal surgery affecting stoma site

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Central Study Contacts

Xiang Zhang, M.D. Ph.D.

CONTACT

+8618560089182; xiang.zhang02@hotmail.com

Yanlei Wang, M.D. Ph.D.

CONTACT

+8618560085128

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share