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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Northwestern University • ClinicalTrials.gov ID: NCT07881354

Registry updated: 2026-10-19
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Description

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.

Interventions

  • Duramesh (Device)
    #1 Duramesh sutures
  • Mesh (Device)
    Coated polypropylene intraperitoneal mesh

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

Conditions

Umbilical Hernia Ventral Hernia

Locations

  • Northwestern Memorial Hospital — Chicago, Illinois, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record