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

NCT06511414 | Recruiting FDA Device

• 1 other identifier: STU00220106
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Incisional Hernia; Ileostomy - Stoma

Keywords

duramesh,

Outcome Measures

Primary Outcomes (1)

• hernia rates

  Compare hernia rates after ileostomy closure between Duramesh™ and standard monofilament closure

  1 year

Secondary Outcomes (1)

• infection rate

  1 year

Study Arms (2)

Duramesh

EXPERIMENTAL

using duramesh suture for ileostomy fascial closure

Device: duramesh

Control

ACTIVE COMPARATOR

standard ileostomy fascial closure

Device: Control

Interventions

duramesh DEVICE

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

Duramesh

Control DEVICE

standard closure of fascia

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Central Study Contacts

tomek wojtasik

CONTACT

312.503.5291; tomasz.wojtasik@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Section of Colon and Rectal Surgery

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: January 3, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)