Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
154 participants
INTERVENTIONAL
2022-11-14
2031-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Incisional hernia repair
Participants will undergo incisional hernia repair
Primary closure (Intervention arm)
Participants will undergo incisional hernia repair with suture alone using modern surgical techniques.
Incisional hernia repair
Participants will undergo incisional hernia repair
Interventions
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Incisional hernia repair
Participants will undergo incisional hernia repair
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Clayton Petro
OTHER
Responsible Party
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Clayton Petro
Assistant Professor
Principal Investigators
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Clayton Petro, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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University of Florida
Gainesville, Florida, United States
Northwestern
Chicago, Illinois, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Vanderbilt University
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Richard Pierce, MD, PhD
Role: primary
References
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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.
Other Identifiers
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22-945
Identifier Type: -
Identifier Source: org_study_id
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