Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak. Ileostomy will be reversed with restoration of continuity in majority of patients. Stoma site incisional hernias after ileostomy closure are complex hernias that can be associated with abdominal pain, discomfort, and a diminished quality of life. Duramesh™ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure. The Aim of this study is to evaluate Duramesh™ suture vs standard closure on rates of hernia formation after ileostomy closure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• • Patients undergoing ileostomy closure after surgery for cancer All patients with a stoma (independent of diagnosis)

‣ Age 18 or greater

⁃ Surgical oncology patient where routine radiologic surveillance for malignancy is planned

⁃ Patient accepts participation and gives informed consent

Locations
United States
Illinois
Northwestern University Feinberg School of Medicine
RECRUITING
Chicago
Contact Information
Primary
tomek wojtasik
tomasz.wojtasik@northwestern.edu
312.503.5291
Time Frame
Start Date: 2024-01-03
Estimated Completion Date: 2026-12
Participants
Target number of participants: 106
Treatments
Experimental: Duramesh
using duramesh suture for ileostomy fascial closure
Active_comparator: Control
standard ileostomy fascial closure
Related Therapeutic Areas
Sponsors
Leads: Northwestern University

This content was sourced from clinicaltrials.gov