Observational Study of Anti-Reflux Surgery

Completed

Brief Summary: The Anti-Reflux Surgical Study has been established to:

* Collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and Fundoplication) in everyday clinical practice

* Track the clinical course of patients from pre-operative assessment to three years post-surgery

Detailed Description: This study will track and monitor patients treated with either the magnetic sphincter augmentation or Fundoplication, making it the first Registry to collect data on both anti-reflux surgical options in the setting of everyday clinical experience.

Recruitment & Eligibility

Inclusion Criteria

Individuals treated with LINX Reflux Management System or Fundoplication
Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the Anti-Reflux Surgical Registry.
Individuals willing to complete questionnaires and comply with the three years of follow-up.

Exclusion Criteria

Known circumstances that would make it unlikely for an individual to complete the three year follow-up (e.g. life expectancy <3 years)

Primary Outcome Measures

Name	Time	Method
Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL)	3 years post-surgery	Gastroesophageal Reflux Disease Health Related Quality of Life Outcomes (GERD-HRQL) Total scores range from 0-50 (min/max) 10 questions total, each rating 0-5 (min/max) Lower is better; higher is worse

Secondary Outcome Measures

Name	Time	Method

Locations (21): St. Rochus
🇩🇪
Telgte, Germany
Diako Bremen
🇩🇪
Bremen, Germany
MIC Klinik Berlin
🇩🇪
Berlin, Germany
Knappschafts Krankenhaus Bottrop
🇩🇪
Bottrop, Germany
Herz Jesu Krankenhaus
🇦🇹
Vienna, Austria
Policlinico San Donato
🇮🇹
Milan, Italy
Marien Krankenhaus
🇩🇪
Kassel, Germany
Weymouth Hospital
🇬🇧
Weymouth, United Kingdom
Ruppiner Kliniken
🇩🇪
Neuruppin, Germany
Krankenhaus Herne
🇩🇪
Herne, Germany
Uniklinikum Koln
🇩🇪
Koln, Germany
Epsom and St. Helier Hospital
🇬🇧
Epsom, United Kingdom
Stadtkrankenhaus Schwabach
🇩🇪
Schwabach, Germany
Reflux Centre
🇬🇧
Birmingham, United Kingdom
Klinikum Forchheim
🇩🇪
Forchheim, Germany
Arabella Klinik
🇩🇪
Munchen, Germany
Krankenhaus Castrop Rauxel
🇩🇪
Castrop Rauxel, Germany
Ev. K Zweibrucken
🇩🇪
Zweibrucken, Germany
Royal Devon & Exeter Hospital
🇬🇧
Exeter, United Kingdom
AKH Wien
🇦🇹
Wien, Austria
Spire Tunbridge Wells Hospital
🇬🇧
Tunbridge Wells, United Kingdom