Suture Repair vs Mesh Repair for Incisional Hernia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Incisional Hernia

Intervention / Treatment
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* Procedure: Incisional hernia repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hernia repair with mesh (Control arm)<br>Participants will undergo incisional hernia repair with prolene mesh in the retrorectus position with at least 4cm of overlap. | Procedure: Incisional hernia repair<br>* Participants will undergo incisional hernia repair<br>|
| Active Comparator: Primary closure (Intervention arm)<br>Participants will undergo incisional hernia repair with suture alone using modern surgical techniques. | Procedure: Incisional hernia repair<br>* Participants will undergo incisional hernia repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia specific quality of life | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia specific quality of life | Compare HerQLes summary score at baseline, 30-day, and 2-year follow-up, and 5-year follow up | 5 years | 
| PROMIS-3a-Pain Intensity scores | 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. | 5 years | 
| Recurrence | Compare composite recurrence using clinical, radiographic exam, and Hernia Recurrence Inventory (HRI) at 1-year, and 2-year, and 5 year follow-up postoperatively | 5 years | 
| Complications | 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. | 5 years | 
| Overall quality of life | 4. Compare Euro-QOL-5D-5L with VAS assessment scores at baseline, 30-day, 1-year, 2 years, and 5-year follow-up. | 5 years | 
| Cost effectiveness | 5. Perform a formal cost effectiveness analysis utilizing quality adjusted life years and incremental cost effectiveness ratios. | 5 years |