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

Recruiting

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

Inclusion Criteria:

* Age ≥18 years
* Symptomatic umbilical hernia with fascial defect ≥1 cm
* At least one high-risk comorbidity: BMI ≥30, active smoking, diabetes, or COPD
* Undergoing elective repair

Exclusion Criteria:

* Hernia defect \>6 cm
* Urgent or emergent presentation
* CDC wound class II-IV
* Prior mesh at the umbilicus
* Ascites
* Pregnancy

About the study

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.

What is being tested

Duramesh (device)
Mesh (device)

Sponsor: Northwestern University · Participants: 160 · Started: Oct 23, 2026

Contact the study team

Nancy Ly, MD · Phone: 3126956868

Official record on ClinicalTrials.gov — NCT07881354

Locations in the U.S.

Illinois

Northwestern Memorial Hospital, Chicago

Conditions

Ventral Hernia

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.