Suture Repair vs Mesh Repair for Incisional Hernia

Last updated: January 5, 2026
Sponsor: Clayton Petro
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

Incisional hernia repair

Clinical Study ID

NCT05599750
22-945
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 ofmesh

  • Incisional hernia

Exclusion

Exclusion Criteria:

  • Emergent cases

  • Patients < 18 years old

  • Patients who are pregnant

  • Patients who previously underwent a prior ventral hernia repair with mesh at thesite 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

Study Design

Total Participants: 154
Treatment Group(s): 1
Primary Treatment: Incisional hernia repair
Phase:
Study Start date:
November 14, 2022
Estimated Completion Date:
October 31, 2031

Study 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.

Connect with a study center

  • University of Florida

    Gainesville, Florida 32611
    United States

    Site Not Available

  • University of Florida

    Gainesville 4156404, Florida 4155751 32611
    United States

    Active - Recruiting

  • Northwestern

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • Cleveland Clinic Main Campus

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Cleveland Clinic Main Campus

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Vanderbilt University

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Active - Recruiting

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