Observational Study of Anti-Reflux Surgery

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

Completed

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastro Esophageal Reflux Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AKH Wien, Vienna, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL)

Time frame: 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

Sponsors and collaborators

Lead sponsor

Torax Medical Incorporated

Industry

Registry information

Official study title

Observational Study of Anti-Reflux Surgery: Clinical Experience With the LINX Reflux Management System and Fundoplication

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2018
First posted: Jun 20, 2012
Registry last updated: Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed