An interventional study of Duramesh and Mesh in Umbilical Hernia and Ventral Hernia, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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 care and discharge analgesia are standardized across arms. Patients are told which repair they received at 1 year, or earlier if they have a recurrence or reoperation.
POD1 pain is collected by a research team member by phone between 9 and 11 AM. Testing is hierarchical and analysis is intent-to-treat. Non-inferiority is concluded if the upper bound of the two-sided 95% CI for the mean difference (Duramesh - IPOM) is below 2 points, the minimal clinically important difference. If non-inferiority is shown, superiority is tested. The sample size of 64 per arm assumes a mean POD1 NRS of 5, an SD of 2.5 (Petro et al., 2021), one-sided alpha 0.025, and 80% power. It is inflated to 80 per arm to allow for 20% loss to follow-up.
Most secondary outcomes come from the Abdominal Core Health Quality Collaborative (ACHQC) registry, which collects them as standard of care. Recurrence is determined by a consensus algorithm that combines clinical exam, CT, and the Ventral Hernia Recurrence Inventory, with CT used to confirm a suspected recurrence on exam. Rectus diastasis is recorded in all patients, and a prespecified subgroup analysis compares outcomes in patients with and without it.
70 studies on the registry are indexed under Hernia, Umbilical; 14 are open to participants now.
This study's planned enrollment of 160 is above the median of 66 across 42 interventional studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Duramesh
Laparoscopic or robotic repair with fascial defect closure and intraperitoneal coated polypropylene mesh (≥4 cm overlap), fixed with sutures or permanent tacks. General anesthesia.
Device: Mesh
#1 Duramesh sutures
Also known as: mesh suture
Coated polypropylene intraperitoneal mesh
Also known as: coated polypropylene intraperitoneal mesh
Postoperative Day 1 Pain
Pain on the Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable), collected by phone.
Time frame: Postoperative Day 1
Postoperative pain on day of surgery
Pain intensity measured with the Numeric Rating Scale (NRS) for pain, scored from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain.
Time frame: Post-anesthesia care unit, day of surgery
Postoperative Day 7 Pain
Pain intensity measured with the Numeric Rating Scale (NRS) for pain, scored from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain.
Time frame: Postoperative day 7
Wound complications
seroma, suture sinus, and mesh-related complications
Time frame: 30 days, 1 year and 2 year
Hospital readmissions
Hospital readmissions following surgery
Time frame: 30 day, 1 year, 2 year
Reoperations
Events where reoperation is done for the hernia
Time frame: 30 day, 1 year, 2 year
Return to Normal Activity
Number of patients reporting a full return to preoperative daily activities
Time frame: 30 days
Hernia Recurrence
Recurrence by consensus definition (clinical exam, CT imaging, and Ventral Hernia Recurrence Inventory survey)
Time frame: 1 and 2 years
Hospital Admission After Surgery
Proportion of patients requiring admission instead of same-day discharge, and time in recovery before discharge
Time frame: Postoperative day zero, index hospitalization
Costs
OR direct costs; hospital direct costs; procedural costs
Time frame: Baseline through hospital discharge, average 5 days
Plan to share: No — Data are held in the ACHQC registry under its data-use policies, and there is no current plan to share individual participant data.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 18 interventional studies with no phase under Hernia, Umbilical, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 47. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.