Comparing suture and mesh methods for repairing incisional hernias
A Modern Comparison of Suture Repair With Mesh Repair for Incisional Hernia
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 5 sites (Gainesville, Florida and 4 other locations) |
| Trial ID | NCT05599750 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gainesville, Florida and 4 other locations
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Northwestern — Chicago, Illinois, United States (Recruiting)
- Cleveland Clinic Main Campus — Cleveland, Ohio, United States (Recruiting)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Not_yet_recruiting)
- Vanderbilt University — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Clayton Petro, MD — The Cleveland Clinic
- Study coordinator: Clayton Petro, MD
- Email: petroc@ccf.org
- Phone: 2169242930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.