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RECRUITING
NCT07881354
NA

Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs

Sponsor: Northwestern University

View on ClinicalTrials.gov

Summary

Umbilical hernias are common, and repair with mesh lowers the risk of the hernia coming back compared with stitches alone. Most evidence comes from lower-risk patients. Patients with obesity, diabetes, smoking, or COPD have more complications after hernia repair, and the best repair for them is unclear. Minimally invasive intraperitoneal onlay mesh (IPOM) places mesh inside the abdomen, which may cause pain and long-term mesh problems. Duramesh is a mesh suture that spreads tension across the repair and avoids placing flat mesh in the abdomen. This randomized trial will compare Duramesh repair with minimally invasive IPOM in 160 high-risk adults having elective umbilical hernia repair at Northwestern Medicine. The main question is whether pain on the day after surgery with Duramesh is no worse than with IPOM. The study will also compare complications, quality of life, return to normal activity, costs, and hernia recurrence up to 2 years after surgery.

Official title: Duramesh Versus Minimally Invasive Intraperitoneal Onlay Mesh (IPOM) for High-Risk Umbilical Hernia Repairs: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-10

Completion Date

2029-10

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

DEVICE

Duramesh

#1 Duramesh sutures

DEVICE

Mesh

Coated polypropylene intraperitoneal mesh

Locations (1)

Northwestern Memorial Hospital

Chicago, Illinois, United States