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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02923362
Study type Observational [Patient Registry]
Source The Heartburn Foundation
Contact
Status Active, not recruiting
Phase
Start date May 2016
Completion date May 2025

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