Observational Study of Anti-Reflux Surgery

Completed

• Conditions: GERD; Gastro Esophageal Reflux; Gastroesophageal Reflux

• Registration Number: NCT01624506
• Lead Sponsor: Torax Medical Incorporated

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-20
• Primary Completion: 2015-01
• Study Completion: 2018-07
• Results First Submitted: 2021-04-19
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-13
• Last Update Submitted: 2021-05-13
• Results First Posted: 2021-06-08
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 760

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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

Trial Locations

Locations (21)

Herz Jesu Krankenhaus; 🇦🇹 Vienna, Austria

AKH Wien; 🇦🇹 Wien, Austria

MIC Klinik Berlin; 🇩🇪 Berlin, Germany

Knappschafts Krankenhaus Bottrop; 🇩🇪 Bottrop, Germany

Diako Bremen; 🇩🇪 Bremen, Germany

Krankenhaus Castrop Rauxel; 🇩🇪 Castrop Rauxel, Germany

Klinikum Forchheim; 🇩🇪 Forchheim, Germany

Krankenhaus Herne; 🇩🇪 Herne, Germany

Marien Krankenhaus; 🇩🇪 Kassel, Germany

Uniklinikum Koln; 🇩🇪 Koln, Germany

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