Comparing suture and mesh methods for repairing incisional hernias
Official title: A Modern Comparison of Suture Repair With Mesh Repair for Incisional Hernia
Run by The Cleveland Clinic · NCT05599750 · Data updated 2026-11-12
This study is testing whether using stitches instead of mesh for fixing incisional hernias helps people feel just as good one year after surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 154 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 5 sites (Gainesville, Florida and 4 other locations) |
| Status | Recruiting |
| Started | November 14, 2022 |
| Main results expected | October 2026 |
| Study ends | October 2031 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT05599750 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with a non-emergent incisional hernia measuring 2-6cm and who have not previously had mesh used in a ventral hernia repair.
✕Probably not a fit
Patients with emergent cases, those under 18, or individuals who have had prior mesh repairs at the intended site may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial aims to evaluate the quality of life outcomes one year after incisional hernia repair using either synthetic mesh or suture techniques. The study will assess whether primary suture repair is non-inferior to mesh repair for hernias measuring 2-6cm. Patients will be blinded to the type of intervention they receive, and the primary outcome will be measured using the HerQLes summary score. The trial is designed to provide insights into the effectiveness of these two surgical approaches.
Why it matters
Potential benefit: If successful, this study could provide evidence that suture repair is a viable alternative to mesh repair, potentially leading to improved patient outcomes and quality of life.
How similar studies have gone: Other studies have explored various surgical techniques for hernia repair, but this specific comparison of suture versus mesh in a non-inferiority framework is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults \>18 years old. * Anticipated hernia defect 2-6cm in width * Non-emergent case * CDC class I * Patients who previously underwent primary ventral hernia repair without the use of mesh * Incisional hernia Exclusion Criteria: * Emergent cases * Patients \< 18 years old * Patients who are pregnant * Patients who previously underwent a prior ventral hernia repair with mesh at the site of the intended repair. Abdominal mesh in separate locations would be allowed. * Ventral hernia \<2cm or \> 6 cm in width * Primary hernia * CDC wound class II-IV
Where it's running
-
University of Florida
Gainesville, Florida, United States Recruiting -
Northwestern
Chicago, Illinois, United States Recruiting -
Cleveland Clinic Main Campus
Cleveland, Ohio, United States Recruiting -
Vanderbilt University
Nashville, Tennessee, United States Recruiting -
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States Not yet recruiting
Study contacts
- Principal investigator: Clayton Petro, MD — The Cleveland Clinic
- Study coordinator: Clayton Petro, MD
- Email: petroc@ccf.org
- Phone: 2169242930
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.