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NCT05599750NARecruitingAccepts Healthy Volunteers

Suture Repair vs Mesh Repair for Incisional Hernia

Clayton Petro

Start Date

11/14/2022

Completion Date

10/1/2031

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.

Detailed Description

This is a patient-blinded randomized control trial comparing incisional hernia repair using synthetic mesh versus suture repair. This is a non-inferiority trial theorizing that suture repair will be non-inferior with respect to quality of life (using the HerQLes survey) at 1 year postoperatively. Patients will be blinded to the intervention, groups will be in parallel.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

PROCEDURE

Incisional hernia repair

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Conditions

Incisional Hernia

Locations

University of Florida

Gainesville, Florida 32611

United States

Northwestern

Chicago, Illinois 60611

United States

Cleveland Clinic Main Campus

Cleveland, Ohio 44195

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States

Vanderbilt University

Nashville, Tennessee 37232

United States