NCT07881354|RecruitingFDA Device
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Sponsor study identifier
interventional
160
1 country
1
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 5, 2026
Actual (reported)October 19, 2026
Actual (reported)October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Postoperative Day 1 Pain
Pain on the Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable), collected by phone.
Postoperative Day 1
Postoperative pain on day of surgery
Post-anesthesia care unit, day of surgery
Postoperative Day 7 Pain
Postoperative day 7
Wound complications
30 days, 1 year and 2 year
Hospital readmissions
30 day, 1 year, 2 year
Reoperations
30 day, 1 year, 2 year
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.
Laparoscopic or robotic repair with fascial defect closure and intraperitoneal coated polypropylene mesh (≥4 cm overlap), fixed with sutures or permanent tacks. General anesthesia.
#1 Duramesh sutures
Coated polypropylene intraperitoneal mesh
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
First Submitted
October 5, 2026
First Posted
October 19, 2026
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
October 2027
Preperitoneal Umbilical Mesh Area
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 23, 2026
Record last verified: 2026-10
Data are held in the ACHQC registry under its data-use policies, and there is no current plan to share individual participant data.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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