Comparing mesh and sutures for paraesophageal hernia repair
Official title: A Randomized, Blinded, Parallel-group Trial Evaluating Mesh Versus Pledgeted Sutures in Paraesophageal Hernia Recurrence
Run by The Cleveland Clinic · NCT05974722 · Data updated 2026-11-12
This study is testing whether using a special mesh or stitches works better to prevent paraesophageal hernias from coming back after surgery for people who need this repair.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 164 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | September 11, 2023 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT05974722 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with Type II, III, or IV hiatal hernias greater than 5 cm.
✕Probably not a fit
Patients who are pregnant, have a BMI over 45, or have undergone previous hiatal hernia repairs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effectiveness of Ovitex mesh versus pledgeted suture closure in reducing the recurrence of paraesophageal hernias over a two-year period. Conducted at the Cleveland Clinic, the study will enroll 164 patients who meet specific inclusion criteria and will be monitored for quality of life and recurrence rates post-surgery. The trial employs a randomized, single-blind design to minimize bias, with blinded outcome assessors evaluating the results. Participants will be followed for a total of seven years to assess long-term outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients undergoing paraesophageal hernia repair.
How similar studies have gone: Other studies have shown promising results with the use of mesh in hernia repairs, suggesting that this approach may be beneficial.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Cleveland Clinic Center for Abdominal Core Health
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: David M Krpata, MD — The Cleveland Clinic
- Study coordinator: David M Krpata, MD
- Email: krpatad@ccf.org
- Phone: 216 445-3441
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.