Observational Study of Anti-Reflux Surgery

Torax Medical Incorporated760 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

760

Conditions

GERD Gastroesophageal Reflux Gastro Esophageal Reflux

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (21)

AKH Wien

Vienna, Austria

Herz Jesu Krankenhaus

Vienna, Austria

Outcomes

Primary Outcomes

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

Time frame: 3 years post-surgery

Data from ClinicalTrials.gov

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