Suture Repair vs Mesh Repair for Incisional Hernia
Purpose
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.
Condition
- Incisional Hernia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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 Criteria
- 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
- Masking Description
- Participants will be blinded to intervention. Recurrence on imaging will be assessed by blinded assessors
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Nashville, Tennessee 37232
Richard Pierce, MD, PhD
More Details
- Status
- Recruiting
- Sponsor
- Clayton Petro
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.