Suture Repair vs Mesh Repair for Incisional Hernia

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Clayton Petro
Study ID
NCT05599750
Status
Recruiting
Apply to this trial

Conditions

  • Incisional Hernia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Incisional hernia repair — PROCEDURE
    Participants will undergo incisional hernia repair

Study Details

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.

Key Dates

Start date
Nov 14, 2022
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2031

Study Design

Enrollment
154 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Primary closure (Intervention arm)
    Participants will undergo incisional hernia repair with suture alone using modern surgical techniques.

Primary Outcome Measure

Hernia specific quality of life [ Time Frame: 1 year ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611
Mazen Al-Mansour, MD
[email protected]
NorthwesternChicagoIllinois60611
Michael J Rosen, MD
[email protected]
312-695-4835
Harika Reddy, MPH
[email protected]
312-503-3929
Cleveland Clinic Main CampusClevelandOhio44195
William Bennett, MD
[email protected]
216-313-8971
The Ohio State University Wexner Medical CenterColumbusOhio43210
Benjamin Poulose, MD
[email protected]
Kayla Diaz
[email protected]
Benjamin Poulose, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt UniversityNashvilleTennessee37232
Richard Pierce, MD, PhD

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University of Florida· Gainesville, FLNorthwestern· Chicago, ILCleveland Clinic Main Campus· Cleveland, OHThe Ohio State University Wexner Medical Center· Columbus, OHVanderbilt University· Nashville, TN

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