Mesh Vs Pledgets for Repair of Paraesophageal Hernia

Recruiting now · Not applicable

Conditions studied: Paraesophageal Hernia, GERD

In brief

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

Key facts

Study ID: NCT05974722
Run by: David Krpata
People needed: 164
Starts: 2023-09-11
Expected to finish: 2028-12-01
Last updated by the study team: 2025-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Cleveland Clinic Center for Abdominal Core Health — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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