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

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Jun 29, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways of creating a stoma, which is an opening made during certain bowel surgeries to allow waste to leave the body. The study wants to find out if a newer surgical method, called the extraperitoneal approach via the arcuate line, can lower the chance of developing a parastomal hernia—a common complication where a bulge forms near the stoma—compared to the traditional method that goes through the abdominal cavity. The hope is that this new technique will lead to fewer problems after surgery and improve the quality of life for patients who need a permanent stoma.

People who might join this study are adults between 18 and 80 years old who are scheduled to have a specific type of bowel surgery called laparoscopic abdominoperineal resection. To take part, they need to be able to give informed consent, meaning they understand the study and agree to join. Those with previous hernias near the abdomen, emergency surgeries, serious health issues that make surgery unsafe, or past surgeries affecting the stoma area would not be eligible. Participants can expect to be randomly assigned to one of the two surgical methods and will be followed afterward to see which technique works better at preventing hernias. This study has not started recruiting yet but aims to help improve care for people needing stomas.

Gender

ALL

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