Suture Repair vs Mesh Repair for Incisional Hernia

Incisional Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599750
• Other study ID #: 22-945
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: October 2031

Study information

• Verified date: March 2024
• Source: The Cleveland Clinic
• Contact: Clayton Petro, MD
• Phone: 2169242930
• Email: petroc[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: October 2031
• Est. primary completion date: October 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Procedure:
• Incisional hernia repair
Participants will undergo incisional hernia repair

Locations

Country	Name	City	State
United States	Cleveland Clinic Main Campus	Cleveland	Ohio
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Clayton Petro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cost effectiveness	5. Perform a formal cost effectiveness analysis utilizing quality adjusted life years and incremental cost effectiveness ratios.	5 years