Suture Repair vs Mesh Repair for Incisional Hernia
- Conditions
- Incisional Hernia
- Interventions
- Procedure: Incisional hernia repair
- Registration Number
- NCT05599750
- Lead Sponsor
- Clayton Petro
- Brief 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.
- Detailed Description
This is a patient-blinded randomized control trial comparing incisional hernia repair using synthetic mesh versus suture repair. This is a non-inferiority trial theorizing that suture repair will be non-inferior with respect to quality of life (using the HerQLes survey) at 1 year postoperatively. Patients will be blinded to the intervention, groups will be in parallel.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 154
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Primary closure (Intervention arm) Incisional hernia repair Participants will undergo incisional hernia repair with suture alone using modern surgical techniques. Hernia repair with mesh (Control arm) Incisional hernia repair Participants will undergo incisional hernia repair with prolene mesh in the retrorectus position with at least 4cm of overlap.
- Primary Outcome Measures
Name Time Method Hernia specific quality of life 1 year Suture repair will be compared to mesh repair for incisional hernias 2-6cm with respect to quality of life using the Hernia-specific Quality of Life (HerQLes) summary score at one year postoperatively. This is reported as a score from 0-100 with higher numbers indicating better quality of life.
- Secondary Outcome Measures
Name Time Method Hernia specific quality of life 5 years Compare HerQLes summary score at baseline, 30-day, and 2-year follow-up, and 5-year follow up
PROMIS-3a-Pain Intensity scores 5 years Compare PROMIS-3a-Pain Intensity scores (a validated measure of pain) at baseline, 30-day, 1-year, 2 years, and 5- year follow up. Scores are reported as raw values from 3-15 or as T-scores from 30.7-71.8, with higher numbers indicating more pain.
Recurrence 5 years Compare composite recurrence using clinical, radiographic exam, and Hernia Recurrence Inventory (HRI) at 1-year, and 2-year, and 5 year follow-up postoperatively
Complications 5 years Compare all complications at 30-day, 1-year, 2-year, and 5-year follow-up postoperatively. This includes occurrence of surgical site infections, surgical site occurrence requiring intervention, readmissions, hernia related reoperation, or mortality.
Overall quality of life 5 years 4. Compare Euro-QOL-5D-5L with VAS assessment scores at baseline, 30-day, 1-year, 2 years, and 5-year follow-up.
Cost effectiveness 5 years 5. Perform a formal cost effectiveness analysis utilizing quality adjusted life years and incremental cost effectiveness ratios.
Trial Locations
- Locations (4)
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Cleveland Clinic Main Campus
🇺🇸Cleveland, Ohio, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States