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Ovitex Mesh vs. Pledgeted Sutures for Paraesophageal Hernia Repair

This study is comparing two ways to repair a paraesophageal hernia (when part of the stomach pushes up into the chest): using Ovitex Mesh or using pledgeted sutures (stitches reinforced with small pads). Researchers want to see if Ovitex Mesh leads to fewer hernias coming back after two years. They will also look at your quality of life after surgery. You might be able to join if you are 18 or older, have a specific type of hiatal hernia (a hernia larger than 5 cm), and are willing to participate in follow-up visits. This study is currently recruiting 164 participants.

Study design
This is a randomized study, meaning you would be assigned by chance to one of two treatment groups. It will involve 164 participants and is designed so you won't know which treatment you received.
What's involved
You would have follow-up visits at 1 month and then yearly for 2 years after surgery. The total estimated duration for your participation is 4 years, with an additional 3 years for longer-term follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 2 years to check for hernia recurrence, with additional follow-up for a total of 7 years.

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NCT05974722

Mesh Vs Pledgets for Repair of Paraesophageal Hernia

Recruiting
NAAges 18+InterventionalPrevention
David Krpata
~164 participants
Updated 2025-10-07 on ClinicalTrials.gov
What's tested:OviTex MeshPledgeted sutures

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic recurrence rate
Measured over 2 years after surgery

Conditions

Paraesophageal Hernia
GERD

Explore related trials

Gastroesophageal Reflux DiseaseParaesophageal hernia

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • David M Krpata, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

David M Krpata, MD
[email protected]
216 445-3441
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Radiographic recurrence rate2 years after surgery

    The primary endpoint of this study is the binary 2-year rate of radiographic recurrence of the paraesophageal hernia, defined gastroesophageal junction at least 2 cm above the hiatus on upper gastrointestinal studies, CT, or MRI.