A modern comparison of suture repair versus mesh repair for incisional hernia: a study protocol for a randomized controlled trial.
Sara M Maskal, Benjamin T Miller, Ryan C Ellis...
https://pubmed.ncbi.nlm.nih.gov/41163187Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05599750
A Modern Comparison of Suture Repair With Mesh Repair for Incisional Hernia
Led by Clayton Petro · Updated on 2026-01-07
154
Participants Needed
5
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the quality of life outcomes in patients undergoing surgery for incisional hernias. This trial compares two surgical methods: repair using synthetic mesh and repair using sutures alone, focusing on hernias sized 2 to 6 cm. The study is designed as a patient-blinded randomized control trial to test if suture repair is not worse than mesh repair in terms of quality of life one year after surgery. Participants will be randomly assigned to one of two groups. One group will receive incisional hernia repair with prolene mesh placed in the retrorectus position with at least 4 cm of overlap. The other group will have the hernia repaired using only sutures with modern surgical techniques. Both groups will be followed in parallel, and participants will not know which treatment they received. During the study, researchers will assess quality of life using the HerQLes survey at one year, which is the primary outcome. Secondary outcomes include long-term quality of life, pain intensity, hernia recurrence, complications, overall quality of life, and cost effectiveness measured over five years. Participants are expected to be monitored regularly for these outcomes, and the total study duration extends up to several years to observe long-term effects.
CONDITIONS
Brief Title
Suture Repair vs Mesh Repair for Incisional Hernia
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 1 day to 2 weeks or until discharge
Participants undergo incisional hernia repair surgery using either synthetic mesh or suture repair and receive immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Post-operative Follow-up
Duration - Up to 5 years
Participants are followed after surgery to monitor recovery, quality of life, and any complications.
Periodic visits over 5 years for assessments
Trial Site Locations
Total: 5 locations
1
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
2
Northwestern
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
Actively Recruiting
4
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Not Yet Recruiting
5
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
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Research Team
C
Clayton Petro, MD
W
William Bennett, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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