Northwestern University
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.
This single-center, registry-based randomized trial tests whether Duramesh suture repair is non-inferior to minimally invasive IPOM for postoperative pain in high-risk patients undergoing umbilical hernia repair. Randomization is performed in clinic after consent, using REDCap with a fixed block size of 4. This allows the operating room to be set up in advance. All patients receive preoperative bilateral ultrasound-guided rectus sheath blocks with 0.5% bupivacaine. Port sites, sham incisions, and periumbilical incisions are infiltrated with 0.25% bupivacaine with epinephrine. Postoperative c…
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
#1 Duramesh sutures
Coated polypropylene intraperitoneal mesh
Arctuva estimate
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