RECRUITING

Suture Repair vs Mesh Repair for Incisional Hernia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-11-14
Study Completion:2031-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05599750

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults \>18 years old.
  2. * Anticipated hernia defect 2-6cm in width
  3. * Non-emergent case
  4. * CDC class I
  5. * Patients who previously underwent primary ventral hernia repair without the use of mesh
  6. * Incisional hernia
  1. * Emergent cases
  2. * Patients \< 18 years old
  3. * Patients who are pregnant
  4. * 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.
  5. * Ventral hernia \<2cm or \> 6 cm in width
  6. * Primary hernia
  7. * CDC wound class II-IV

Contacts and Locations

Study Contact

Clayton Petro, MD
CONTACT
2169242930
petroc@ccf.org
Sara Maskal, MD
CONTACT
2168705655
maskals2@ccf.org

Principal Investigator

Clayton Petro, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32611
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

Collaborators and Investigators

Sponsor: Clayton Petro

  • Clayton Petro, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-14
Study Completion Date2031-10

Study Record Updates

Study Start Date2022-11-14
Study Completion Date2031-10

Terms related to this study

Additional Relevant MeSH Terms

  • Incisional Hernia