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NCT Number: NCT07056868

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of Parastomal Hernia

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiang Zhang, M.D. Ph.D.

CONTACT

[email protected]

+8618560089182

Yanlei Wang, M.D. Ph.D.

CONTACT

+8618560085128

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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