+1 877 705 191424 / 7
HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 90Years
All Genders
ID03720262

Study of Hernia Prevention After Loop Ileostomy Reversal Using Mesh or Standard Closure in Rectal Cancer Patients

Led by Karolinska Institutet · Updated on 2025-08-19

208

Participants Needed

4

Research Sites

156 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate ways to prevent hernia after loop ileostomy reversal in patients who have undergone rectal cancer surgery. A loop ileostomy is a temporary opening created during rectal cancer surgery that is later closed in a separate operation. Hernia, a weakening of the abdominal wall at the stoma site, can cause pain, discomfort, and serious complications, and its frequency after ileostomy reversal varies widely. This study compares the use of a protective mesh to standard closure methods to see if hernia rates can be reduced. Participants will be randomly assigned to one of two groups one group will receive reinforcement of the abdominal wall with a mesh called Ultrapro Advanced, placed behind the muscles the other group will have the stoma site closed using standard suturing without mesh. The study is double-blinded, meaning neither patients nor surgeons recording follow-up data know which treatment was given. Procedures and outcomes such as operation time, complications, hospital stay, pain, and infections will be carefully recorded. Participants will be monitored before and after surgery, including a 30-day follow-up visit with questionnaires and complication assessments by a doctor not involved in the surgery. One year after the cancer operationwhich generally occurs 6 to 9 months after ileostomy reversalpatients will have a CT scan with straining to check for hernia and complete questionnaires. Further follow-up with questionnaires and imaging will occur at three years. The study involves detailed tracking of post-surgical recovery and hernia development over several years.

CONDITIONS

Brief Title

Prevention of Hernia After Loop Ileostomy Reversal

Research Team

Å

Åsa Hallqvist Everhov, MD, PhD

J

Jonas Nygren, MD, PhD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here