Incisional Hernia
Conditions
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.
Interventions
PROCEDUREIncisional hernia repair
Participants will undergo incisional hernia repair
Sponsors
Clayton Petro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be blinded to intervention. Recurrence on imaging will be assessed by blinded assessors
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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. |
Countries
United States
Contacts
Primary ContactClayton Petro, MD
Backup ContactWilliam Bennett, MD
Outcome results
None listed