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

NCT ID: NCT06511414

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-03

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Incisional Hernia Ileostomy - Stoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Duramesh

using duramesh suture for ileostomy fascial closure

Group Type EXPERIMENTAL

duramesh

Intervention Type 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

Control

standard ileostomy fascial closure

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DEVICE

standard closure of fascia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

duramesh

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

Intervention Type DEVICE

Control

standard closure of fascia

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vitaliy Poylin

Director, Section of Colon and Rectal Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

tomek wojtasik

Role: CONTACT

312.503.5291

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Vitaliy Poylin

Role: primary

312-926-5149

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU00220106

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Permacol Dutch Cohort Study
NCT02166112 COMPLETED