Using a special mesh to improve hiatal hernia surgery outcomes
Official title: The Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair in Robotic Anti-Reflux Surgery: A Multi-Institutional Randomized Trial
Run by Weill Medical College of Cornell University · NCT06444347 · Data updated 2026-11-12
This study tests whether using a special mesh during hiatal hernia surgery can help prevent the hernia from coming back in adults with gastroesophageal reflux disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Status | Recruiting |
| Started | June 10, 2024 |
| Main results expected | July 2027 |
| Study ends | July 2030 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT06444347 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a documented diagnosis of gastroesophageal reflux disease who are scheduled for anti-reflux surgery.
✕Probably not a fit
Patients who are undergoing emergency surgery or have conditions like documented dementia or pregnancy 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 study investigates whether the use of a biosynthetic mesh during anti-reflux surgery can decrease the recurrence rate of hiatal hernias. Participants will be randomly assigned to receive either the mesh or standard surgery without it. The goal is to determine if the mesh provides a significant advantage in preventing hernia recurrence post-surgery. The study focuses on adults diagnosed with gastroesophageal reflux disease who are scheduled for surgical intervention.
Why it matters
Potential benefit: If successful, this approach could lead to lower rates of hiatal hernia recurrence, improving patient outcomes after surgery.
How similar studies have gone: While the use of mesh in hernia repairs is common, this specific application in hiatal hernia surgery is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented diagnosis of gastroesophageal reflux disease * Adults aged 18 years or older * English speaking * Subject is planned to undergo surgery for reflux disease Exclusion Criteria: * Physician deems the subject is unable to complete the study due to documented dementia. * Subject is undergoing emergent surgery. * Pregnancy * Patient has known allergy to tetracycline hydrochloride or kanamycin sulfate
Where it's running
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Weill Cornell Medicine
New York, New York, United States Recruiting -
University of Southern California Keck School of Medicine
Los Angeles, California, United States Withdrawn -
Louisiana State University School of Medicine
New Orleans, Louisiana, United States Withdrawn -
Washington University School of Medicine
St Louis, Missouri, United States Withdrawn -
NYU Langone Health
New York, New York, United States Not yet recruiting -
Lenox Hill Hospital
New York, New York, United States Not yet recruiting
Study contacts
- Principal investigator: Rasa Zarnegar, MD — Weill Medical College of Cornell University
- Study coordinator: Annabel Endean, NP
- Email: ant2028@med.cornell.edu
- Phone: 646-962-5250
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.