Suture Repair vs Mesh Repair for Incisional Hernia

Clayton Petro154 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

154

Conditions

Incisional Hernia

Interventions

Incisional hernia repairPROCEDURE

Participants will undergo incisional hernia repair

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

University of Florida

Gainesville, Florida, United States

RECRUITING

Northwestern

Chicago, Illinois, United States

RECRUITING

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

Hernia specific quality of life

Compare HerQLes summary score at baseline, 30-day, and 2-year follow-up, and 5-year follow up

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 5 years

Central Contacts

Clayton Petro, MD

CONTACT

2169242930 petroc@ccf.org

William Bennett, MD

CONTACT

2163138971 bennetw2@ccf.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.