NCT05599750

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
64mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Nov 2022Oct 2031

First Submitted

Initial submission to the registry

October 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

November 14, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2031

Last Updated

January 7, 2026

Status Verified

November 1, 2025

Enrollment Period

3.9 years

First QC Date

October 26, 2022

Last Update Submit

January 5, 2026

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Hernia specific quality of life

    5 years

  • PROMIS-3a-Pain Intensity scores

    5 years

  • Recurrence

    5 years

  • Complications

    5 years

  • Overall quality of life

    5 years

  • +1 more secondary outcomes

Study Arms (2)

Hernia repair with mesh (Control arm)

ACTIVE COMPARATOR

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

Procedure: Incisional hernia repair

Primary closure (Intervention arm)

ACTIVE COMPARATOR

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

Procedure: Incisional hernia repair

Interventions

Incisional hernia repairPROCEDURE

Participants will undergo incisional hernia repair

Hernia repair with mesh (Control arm)Primary closure (Intervention arm)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

Northwestern

Chicago, Illinois, 60611, United States

RECRUITING

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Vanderbilt University

Nashville, Tennessee, 37232, United States

RECRUITING

Related Publications (1)

  • Maskal SM, Miller BT, Ellis RC, Beffa LRA, Prabhu AS, Rosen MJ, Krpata DM, Huang LC, Petro CC. A modern comparison of suture repair versus mesh repair for incisional hernia: a study protocol for a randomized controlled trial. Trials. 2025 Oct 29;26(1):450. doi: 10.1186/s13063-025-08924-5.

    PMID: 41163187DERIVED

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Clayton Petro, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clayton Petro, MD

CONTACT

2169242930petroc@ccf.org

William Bennett, MD

CONTACT

2163138971bennetw2@ccf.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be blinded to intervention. Recurrence on imaging will be assessed by blinded assessors
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 26, 2022

First Posted

October 31, 2022

Study Start

November 14, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2031

Last Updated

January 7, 2026

Record last verified: 2025-11

Locations

US(5)