Recruiting

Suture Repair vs. Mesh Repair

Sponsor:

Clayton Petro

Code:

NCT05599750

Conditions

Incisional Hernia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Incisional hernia repair

Study Details

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.

Conditions

Incisional Hernia

Study ID

NCT05599750

Start date

Nov 14, 2022

Status verified date

Nov, 2025

Completion date

Oct, 2031

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

154 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Hernia repair with mesh (Control arm)

Participants will undergo incisional hernia repair with prolene mesh in the retrorectus position with at least 4cm of overlap.

active comparator: Primary closure (Intervention arm)

Participants will undergo incisional hernia repair with suture alone using modern surgical techniques.

Interventions

Incisional hernia repair

Participants will undergo incisional hernia repair

Primary outcome measure

  • Hernia specific quality of life [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Clayton Petro, MD

2169242930petroc@ccf.org

William Bennett, MD

2163138971bennetw2@ccf.org

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Mazen Al-Mansour, MD

mazen.al-mansour@surgery.ufl.edu

Northwestern

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Michael J Rosen, MD

312-695-4835michael.rosen@nm.org

Harika Reddy, MPH

312-503-3929harika.reddy@northwestern.edu

Cleveland Clinic Main Campus

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

William Bennett, MD

216-313-8971bennetw2@ccf.org

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Clayton Petro

Last update posted

Jan 7, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Clayton Petro on 2026-01-07.