Status:
RECRUITING
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Lead Sponsor:
David Krpata
Conditions:
Paraesophageal Hernia
GERD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 par...
Detailed Description
This is a prospective, single-center, randomized, two-arm trial assessing the impact of Ovitex mesh on paraesophageal hernia recurrence. This study will occur at Cleveland Clinic Foundation in Clevela...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Willing and able to provide informed consent
- Willing and able to participate in long-term follow up including study visits and surveys
- Type II, III, or IV hiatal hernia \> 5 cm, confirmed via upper GI studies, CT, or MRI 5 cm or greater hernia confirmed intraoperatively
Exclusion
- Pregnancy
- BMI \>45
- Allergy to any components of mesh
- Patients undergoing PEHR with a concurrent bariatric procedure or other procedure to reduce stomach volume (sleeve gastrectomy, roux-en-y gastric bypass, duodenal switch, single-anastomosis gastric bypass, and partial or total gastrectomy)
- Patients who have undergone previous hiatal hernia repair
Key Trial Info
Start Date :
September 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT05974722
Start Date
September 11 2023
End Date
December 1 2028
Last Update
October 7 2025
Active Locations (1)
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1
Cleveland Clinic Center for Abdominal Core Health
Cleveland, Ohio, United States, 44195