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Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Sponsor: David Krpata
Summary
The goal of this clinical trial is to compare whether the use of Ovitex mesh provides superior reduction in 2-year recurrence compared to pledgeted suture closure (no mesh) for patients undergoing paraesophageal hernia repair at the Cleveland Clinic. The main questions it aims to answer are: * Determine whether there is a difference in 2-year rates of radiographic recurrence with Ovitex versus pledgeted sutures in paraesophageal hernia repair. * Assess patient quality of life (QOL) after paraesophageal hernia repair with pledgets and mesh. A two-tailed research hypothesis will be used to determine whether there are differences between the two arms
Official title: A Randomized, Blinded, Parallel-group Trial Evaluating Mesh Versus Pledgeted Sutures in Paraesophageal Hernia Recurrence
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
164
Start Date
2023-09-11
Completion Date
2028-12
Last Updated
2025-10-07
Healthy Volunteers
No
Conditions
Interventions
OviTex Mesh
Patient will receive Ovitex Mesh (TELA Bio)
Pledgeted sutures
Patient will receive pledgeted sutures
Locations (1)
Cleveland Clinic Center for Abdominal Core Health
Cleveland, Ohio, United States