Clinical Trial: Registry of Outcomes From AntiReflux Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Registry of Outcomes From AntiReflux Surgery (ROARS)

Brief Summary: Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.

Detailed Summary:

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.

Sponsor: The Heartburn Foundation

Current Primary Outcome: Quality of Life [ Time Frame: 5 Years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The Heartburn Foundation

Dates:
Date Received: October 3, 2016
Date Started: May 2016
Date Completion: May 2023
Last Updated: November 25, 2016
Last Verified: November 2016