Trials / Recruiting
RecruitingNCT06444347
Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair
The Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair in Robotic Anti-Reflux Surgery: A Multi-Institutional Randomized Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Weill Medical College of Cornell University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study is to find out if using a certain kind of mesh can reduce the chances of hiatal hernias coming back after anti-reflux surgery. Participants undergoing antireflux surgery will be assigned to one of two groups, a group that has surgery with mesh, or a group that has surgery without mesh.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Biosynthetic Mesh | The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture. |
| PROCEDURE | Hiatal Hernia Repair | The non-mesh group will undergo hiatal hernia repair with permanent suture only. |
Timeline
- Start date
- 2024-06-10
- Primary completion
- 2026-07-01
- Completion
- 2030-07-01
- First posted
- 2024-06-05
- Last updated
- 2025-11-18
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06444347. Inclusion in this directory is not an endorsement.