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

NANot yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

August 1, 2028

Study Completion Date

October 31, 2028

Conditions
Parastomal HerniaRectal SurgeryStoma ComplicationsExtraperitoneal StomaSurgical Technique Comparison
Interventions
PROCEDURE

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.

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.

All Listed Sponsors
lead

Qilu Hospital of Shandong University

OTHER

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 | Biotech Hunter | Biotech Hunter