Clinical trial NCT01624506: Observational Study of Anti-Reflux Surgery
Official title: Observational Study of Anti-Reflux Surgery: Clinical Experience With the LINX Reflux Management System and Fundoplication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GERD
Gastroesophageal Reflux
Gastro Esophageal Reflux
Keywords: Gastroesophageal Reflux Disease
Fundoplication
Magnetic Sphincter Augmentation
Proton Pump Inhibitors
GERD
PPI
MSA
Lead sponsor: Torax Medical Incorporated
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing antireflux surgery for the treatment of gastroesophageal reflux disease (GERD)

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.

Eligibility criteria: 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 outcomes:
measure: Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL)
timeFrame: 3 years post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Herz Jesu Krankenhaus
city: Wien
country: Austria
facility: AKH Wien
city: Berlin
country: Germany
facility: MIC Klinik Berlin
city: Bottrop
country: Germany
facility: Knappschafts Krankenhaus Bottrop
city: Bremen
country: Germany
facility: Diako Bremen
city: Castrop Rauxel
country: Germany
facility: Krankenhaus Castrop Rauxel
city: Forchheim
country: Germany
facility: Klinikum Forchheim
city: Herne
country: Germany
facility: Krankenhaus Herne
city: Kassel
country: Germany
facility: Marien Krankenhaus
city: Koln
country: Germany
facility: Uniklinikum Koln
city: Munchen
country: Germany
facility: Arabella Klinik
city: Neuruppin
country: Germany
facility: Ruppiner Kliniken
city: Schwabach
country: Germany
facility: Stadtkrankenhaus Schwabach
city: Telgte
country: Germany
facility: St. Rochus
city: Zweibrucken
country: Germany
facility: Ev. K Zweibrucken
city: Milan
country: Italy
facility: Policlinico San Donato
city: Birmingham
country: United Kingdom
facility: Reflux Centre
city: Epsom
country: United Kingdom
facility: Epsom and St. Helier Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital
city: Tunbridge Wells
country: United Kingdom
facility: Spire Tunbridge Wells Hospital
city: Weymouth
country: United Kingdom
facility: Weymouth Hospital
Study officials:
References:
citation: Bonavina L, Horbach T, Schoppmann SF, DeMarchi J. Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication. Surg Endosc. 2021 Jul;35(7):3449-3458. doi: 10.1007/s00464-020-07792-1. Epub 2020 Jul 16.
citation: Riegler M, Schoppman SF, Bonavina L, Ashton D, Horbach T, Kemen M. Magnetic sphincter augmentation and fundoplication for GERD in clinical practice: one-year results of a multicenter, prospective observational study. Surg Endosc. 2015 May;29(5):1123-9. doi: 10.1007/s00464-014-3772-7. Epub 2014 Aug 30.