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

Not Applicable

Recruiting

• Conditions: Incisional Hernia; Ileostomy - Stoma
• Interventions: Device: duramesh; Device: Control

• Registration Number: NCT06511414
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-03
• Status Verified: 2024-07
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• • 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

Exclusion Criteria

• • Pregnancy

  • Prior mesh hernia repair at laparotomy site
  • Life expectancy less than 1 years
  • Patient is unable / unwilling to provide informed consent
  • Patient is unable to comply with the protocol or proposed follow-up visits
  • Patient is enrolled in another hernia study
  • Non-English-speaking participants
  • Data from children will not analyzed in this study.
  • Cognitively Impaired Adults: Data from cognitively impaired adults will not analyzed in this study.
  • Adults Unable to Consent: Data from adults unable to consent will not analyzed in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duramesh	duramesh	using duramesh suture for ileostomy fascial closure
Control	Control	standard ileostomy fascial closure

Primary Outcome Measures

Name	Time	Method
hernia rates	1 year	Compare hernia rates after ileostomy closure between Duramesh™ and standard monofilament closure

Secondary Outcome Measures

Name	Time	Method
infection rate	1 year	Evaluate potential side effects including infections and need for re intervention associated with Duramesh™ vs standard closure

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States