NCT05599750 Suture Repair vs Mesh Repair for Incisional Hernia
| NCT ID | NCT05599750 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Clayton Petro |
| Condition | Incisional Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2022-11-14 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 154 participants in total. It began in 2022-11-14 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques. The main question it aims to answer are: • Determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the HerQLes summary score at one year postoperatively.
Eligibility 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
Contact & Investigator
Clayton Petro, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT05599750 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Incisional Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05599750 currently recruiting?
Yes, NCT05599750 is actively recruiting participants. Contact the research team at petroc@ccf.org for enrollment information.
Where is the NCT05599750 trial being conducted?
This trial is being conducted at Gainesville, United States, Chicago, United States, Cleveland, United States, Columbus, United States and 1 additional location.
Who is sponsoring the NCT05599750 clinical trial?
NCT05599750 is sponsored by Clayton Petro. The principal investigator is Clayton Petro, MD at The Cleveland Clinic. The trial plans to enroll 154 participants.