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RECRUITING
NCT05974722
NA

Mesh Vs Pledgets for Repair of Paraesophageal Hernia

Sponsor: David Krpata

View on ClinicalTrials.gov

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

Interventions

DEVICE

OviTex Mesh

Patient will receive Ovitex Mesh (TELA Bio)

OTHER

Pledgeted sutures

Patient will receive pledgeted sutures

Locations (1)

Cleveland Clinic Center for Abdominal Core Health

Cleveland, Ohio, United States