Suture Repair vs Mesh Repair for Incisional Hernia

Sponsor

The Cleveland Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05599750

Collaborator

(none)

154

Enrollment

Location

Arms

82.6

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Incisional Hernia	Procedure: Incisional hernia repair	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Participants will be blinded to intervention. Recurrence on imaging will be assessed by blinded assessors

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 14, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: Incisional hernia repair Participants will undergo incisional hernia repair
Active Comparator: Primary closure (Intervention arm) Participants will undergo incisional hernia repair with suture alone using modern surgical techniques.	Procedure: Incisional hernia repair Participants will undergo incisional hernia repair

Arm

Intervention/Treatment

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.

Procedure: Incisional hernia repair

Participants will undergo incisional hernia repair

Active Comparator: Primary closure (Intervention arm)

Participants will undergo incisional hernia repair with suture alone using modern surgical techniques.

Procedure: Incisional hernia repair

Participants will undergo incisional hernia repair

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Main Campus	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator: Clayton Petro, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clayton Petro, Assistant Professor, The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT05599750

Other Study ID Numbers:

22-945

First Posted:

Oct 31, 2022

Last Update Posted:

Nov 21, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hernia

Incisional Hernia

Study Results

No Results Posted as of Nov 21, 2022