Using a special mesh to improve hiatal hernia surgery outcomes
The Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair in Robotic Anti-Reflux Surgery: A Multi-Institutional Randomized Trial
NA · Weill Medical College of Cornell University · NCT06444347
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University (other) |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Trial ID | NCT06444347 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are undergoing emergency surgery or have conditions like documented dementia or pregnancy may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Los Angeles, California and 5 other locations
- 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)
- Weill Cornell Medicine — New York, New York, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hiatal Hernia