Trials / Unknown
UnknownNCT02923362
Registry of Outcomes From AntiReflux Surgery
Registry of Outcomes From AntiReflux Surgery (ROARS)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,500 (estimated)
- Sponsor
- The Heartburn Foundation · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.
Detailed description
This is a prospective, multi center, observational database of patients that are having surgical laparoscopic antireflux procedure and/or hiatal hernia repair, including laparoscopic Nissen fundoplication and Magnetic Sphincter Augmentation with the LINX device. Patients meeting registry inclusion and exclusion will be followed for 5 years with standardized quality of life surveys and appropriate standard of care testing. Up to 40 sites will participate with total enrollment of 1000 patients. The main objectives are to collect data from everyday clinical practices and track patients from preoperative assessments to 5 years post surgical intervention to evaluate symptoms, medication use and side effects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Laparoscopic Fundoplication | The gastric fundus of the stomach is wrapped or plicated around the lower end of the esophagus and and stitched in place reinforcing the closing function of the lower esophageal sphincter. The hiatus is also narrowed down with sutures or mesh to prevent or treat a concurrent hiatal hernia. |
| DEVICE | LINX Antireflux | The LINX is a flexible band of interlocked titanium beads with a magnetic core. The LINX is placed around the lower esophageal sphincter to help restore the function of the LES by preventing reflux into the esophagus. |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2023-03-01
- Completion
- 2025-05-01
- First posted
- 2016-10-04
- Last updated
- 2023-02-21
Locations
19 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02923362. Inclusion in this directory is not an endorsement.