Actively Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Led by David Krpata · Updated on 2025-10-07
164
Participants Needed
1
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Willing and able to provide informed consent
- Willing and able to participate in long-term follow-up visits and surveys
- Type II, III, or IV hiatal hernia larger than 5 cm confirmed by upper GI studies, CT, MRI, or intraoperative findings
You will not qualify if you...
- Pregnancy
- Body mass index over 45
- Allergy to any components of the mesh
- Undergoing paraesophageal hernia repair combined with bariatric or other stomach volume reduction surgeries
- Previous hiatal hernia repair surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cleveland Clinic Center for Abdominal Core Health
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
D
David M Krpata, MD
CONTACT
W
William C Bennett, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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