Suture Repair vs Mesh Repair for Incisional Hernia

Description

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 Overview

Study Details

Study overview

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.

A Modern Comparison of Suture Repair With Mesh Repair for Incisional Hernia

Suture Repair vs Mesh Repair for Incisional Hernia

Condition
Incisional Hernia
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida, Gainesville, Florida, United States, 32611

Cleveland

Cleveland Clinic Main Campus, Cleveland, Ohio, United States, 44195

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Nashville

Vanderbilt University, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Clayton Petro,

Clayton Petro, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2031-10