A Modern Comparison of Suture Repair With Mesh Repair for Incisional Hernia
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
Florida
University of Florida
RECRUITING
Gainesville
Ohio
Cleveland Clinic Main Campus
RECRUITING
Cleveland
The Ohio State University Wexner Medical Center
NOT_YET_RECRUITING
Columbus
Tennessee
Vanderbilt University
RECRUITING
Nashville
Contact Information
Primary
Clayton Petro, MD
petroc@ccf.org
2169242930
Backup
Sara Maskal, MD
maskals2@ccf.org
2168705655
Time Frame
Start Date: 2022-11-14
Estimated Completion Date: 2031-10
Participants
Target number of participants: 154
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Clayton Petro