Duramesh repair versus minimally invasive IPOM for high-risk umbilical hernia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized trial compares two surgical approaches for elective umbilical hernia repair in adults with obesity, diabetes, smoking, or COPD. Participants are randomized after consent to receive either Duramesh suture repair or minimally invasive IPOM, with standardized pre- and postoperative care. The primary outcome is postoperative day 1 pain, with non-inferiority defined as the upper bound of the 95% CI for the pain difference not exceeding 2 points on the NRS; if non-inferiority is shown, superiority is tested. Secondary outcomes include complications, quality of life, return to activity, costs, and hernia recurrence up to 2 years. Most secondary data come from the ACHQC registry, and follow-up includes recurrence or reoperation events as applicable.

Why it matters

Who can join: the full rules

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

Where it's running

• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Nancy Ly, MD
• Email: nancy.ly@nm.org
• Phone: 3126956868

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.