Observational Study of Anti-Reflux Surgery
1 other identifier
observational
760
4 countries
21
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 18, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedResults Posted
Study results publicly available
June 8, 2021
CompletedJune 8, 2021
May 1, 2021
5 years
June 18, 2012
April 19, 2021
May 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL)
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
3 years post-surgery
Study Arms (2)
Magnetic Sphincter Augmentation
Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
Fundoplication
Patients treated with laparoscopic fundoplication
Eligibility Criteria
Patients undergoing antireflux surgery for the treatment of gastroesophageal reflux disease (GERD)
You may qualify if:
- 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.
You may not qualify if:
- Known circumstances that would make it unlikely for an individual to complete the three year follow-up (e.g. life expectancy \<3 years)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
AKH Wien
Vienna, Austria
Herz Jesu Krankenhaus
Vienna, Austria
MIC Klinik Berlin
Berlin, Germany
Knappschafts Krankenhaus Bottrop
Bottrop, Germany
Diako Bremen
Bremen, Germany
Krankenhaus Castrop Rauxel
Castrop-Rauxel, Germany
Uniklinikum Koln
Cologne, Germany
Klinikum Forchheim
Forchheim, Germany
Krankenhaus Herne
Herne, Germany
Marien Krankenhaus
Kassel, Germany
Arabella Klinik
München, Germany
Ruppiner Kliniken
Neuruppin, Germany
Stadtkrankenhaus Schwabach
Schwabach, Germany
St. Rochus
Telgte, Germany
Ev. K Zweibrucken
Zweibrücken, Germany
Policlinico San Donato
Milan, Italy
Reflux Centre
Birmingham, United Kingdom
Epsom and St. Helier Hospital
Epsom, United Kingdom
Royal Devon & Exeter Hospital
Exeter, United Kingdom
Spire Tunbridge Wells Hospital
Royal Tunbridge Wells, United Kingdom
Weymouth Hospital
Weymouth, United Kingdom
Related Publications (2)
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.
PMID: 32676727DERIVEDRiegler 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.
PMID: 25171881DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Janet DeMarchi
- Organization
- Ethicon
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2012
First Posted
June 20, 2012
Study Start
January 1, 2010
Primary Completion
January 1, 2015
Study Completion
July 1, 2018
Last Updated
June 8, 2021
Results First Posted
June 8, 2021
Record last verified: 2021-05