Mesh Vs Pledgets for Repair of Paraesophageal Hernia

Recruiting

A Randomized, Blinded, Parallel-group Trial Evaluating Mesh Versus Pledgeted Sutures in Paraesophageal Hernia Recurrence

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

About the study

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

What is being tested

OviTex Mesh (device)
Pledgeted sutures (other)

Sponsor: David Krpata · Participants: 164 · Started: Sep 11, 2023

Contact the study team

David M Krpata, MD · Phone: 216 445-3441
William C Bennett, MD · Phone: 216 313-8971

Official record on ClinicalTrials.gov — NCT05974722

Locations in the U.S.

Ohio	Cleveland Clinic Center for Abdominal Core Health, Cleveland

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.