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Suture Repair vs Mesh Repair for Incisional Hernia

Primary Purpose

Incisional Hernia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incisional hernia repair
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incisional Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cleveland Clinic Main CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hernia repair with mesh (Control arm)

Primary closure (Intervention arm)

Arm Description

Participants will undergo incisional hernia repair with prolene mesh in the retrorectus position with at least 4cm of overlap.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hernia specific quality of life
Compare HerQLes summary score at baseline, 30-day, and 2-year follow-up, and 5-year follow up
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.
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
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.
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.
Cost effectiveness
5. Perform a formal cost effectiveness analysis utilizing quality adjusted life years and incremental cost effectiveness ratios.

Full Information

First Posted
October 26, 2022
Last Updated
November 16, 2022
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05599750
Brief Title
Suture Repair vs Mesh Repair for Incisional Hernia
Official Title
A Modern Comparison of Suture Repair With Mesh Repair for Incisional Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will be blinded to intervention. Recurrence on imaging will be assessed by blinded assessors
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hernia repair with mesh (Control arm)
Arm Type
Active Comparator
Arm Description
Participants will undergo incisional hernia repair with prolene mesh in the retrorectus position with at least 4cm of overlap.
Arm Title
Primary closure (Intervention arm)
Arm Type
Active Comparator
Arm Description
Participants will undergo incisional hernia repair with suture alone using modern surgical techniques.
Intervention Type
Procedure
Intervention Name(s)
Incisional hernia repair
Intervention Description
Participants will undergo incisional hernia repair
Primary Outcome Measure Information:
Title
Quality of life
Description
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 Outcome Measure Information:
Title
Hernia specific quality of life
Description
Compare HerQLes summary score at baseline, 30-day, and 2-year follow-up, and 5-year follow up
Time Frame
5 years
Title
PROMIS-3a-Pain Intensity scores
Description
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
Title
Recurrence
Description
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
Title
Complications
Description
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
Title
Overall quality of life
Description
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
Title
Cost effectiveness
Description
5. Perform a formal cost effectiveness analysis utilizing quality adjusted life years and incremental cost effectiveness ratios.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clayton Petro, MD
Phone
2169242930
Email
petroc@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Maskal, MD
Phone
2168705655
Email
maskals2@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clayton Petro, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Main Campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Maskal, MD
Phone
216-870-5655
Email
MASKALS2@ccf.org

12. IPD Sharing Statement

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Suture Repair vs Mesh Repair for Incisional Hernia

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