RecruitingNot ApplicableNCT05599750

Suture Repair vs Mesh Repair for Incisional Hernia

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


Sponsor

Clayton Petro

Enrollment

154 participants

Start Date

Nov 14, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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

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Interventions

PROCEDUREIncisional hernia repair

Participants will undergo incisional hernia repair


Locations(5)

University of Florida

Gainesville, Florida, United States

Northwestern

Chicago, Illinois, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Vanderbilt University

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT05599750


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