Recruiting

Duramesh vs. IPOM

Sponsor:

Northwestern University

Code:

NCT07881354

Conditions

Umbilical Hernia

Ventral Hernia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Duramesh

Mesh

Study Details

Brief 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.

Conditions

Umbilical Hernia

Ventral Hernia

Study ID

NCT07881354

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Duramesh repair

Open periumbilical repair with interrupted #1 Duramesh sutures and no additional mesh. Includes two sham 5 mm skin incisions for blinding. MAC or general anesthesia.

active comparator: IPOM

Laparoscopic or robotic repair with fascial defect closure and intraperitoneal coated polypropylene mesh (≥4 cm overlap), fixed with sutures or permanent tacks. General anesthesia.

Interventions

Duramesh

#1 Duramesh sutures

Mesh

Coated polypropylene intraperitoneal mesh

Primary outcome measure

  • Postoperative Day 1 Pain [ Time Frame: Postoperative Day 1 ]

Central Contacts and Locations

Central contacts

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

More Information

Sponsor

Northwestern University

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Keywords

  • Duramesh
  • mesh suture
  • intraperitoneal onlay mesh
  • IPOM
  • ventral hernia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.