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NCT05599750
Suture Repair vs Mesh Repair for Incisional Hernia
Conditions: Incisional Hernia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 154
Sponsor: The Cleveland Clinic
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Adults >18 years old.Anticipated hernia defect 2-6cm in widthNon-emergent caseCDC class IPatients who previously underwent primary ventral hernia repair without the use of meshIncisional herniaExclusion Criteria:Emergent casesPatients < 18 years oldPatients who are pregnantPatients 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 widthPrimary herniaCDC wound class II-IV
Source: ClinicalTrials.gov (NCT05599750). StuddyBuddy aggregates publicly available trial information.