Observational Study of Anti-Reflux Surgery

NCT ID: NCT01624506

Last Updated: 2021-06-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

760 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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GERD Gastroesophageal Reflux Gastro Esophageal Reflux

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Magnetic Sphincter Augmentation

Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System

No interventions assigned to this group

Fundoplication

Patients treated with laparoscopic fundoplication

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Torax Medical Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AKH Wien

Vienna, , Austria

Site Status

Herz Jesu Krankenhaus

Vienna, , Austria

Site Status

MIC Klinik Berlin

Berlin, , Germany

Site Status

Knappschafts Krankenhaus Bottrop

Bottrop, , Germany

Site Status

Diako Bremen

Bremen, , Germany

Site Status

Krankenhaus Castrop Rauxel

Castrop-Rauxel, , Germany

Site Status

Uniklinikum Koln

Cologne, , Germany

Site Status

Klinikum Forchheim

Forchheim, , Germany

Site Status

Krankenhaus Herne

Herne, , Germany

Site Status

Marien Krankenhaus

Kassel, , Germany

Site Status

Arabella Klinik

München, , Germany

Site Status

Ruppiner Kliniken

Neuruppin, , Germany

Site Status

Stadtkrankenhaus Schwabach

Schwabach, , Germany

Site Status

St. Rochus

Telgte, , Germany

Site Status

Ev. K Zweibrucken

Zweibrücken, , Germany

Site Status

Policlinico San Donato

Milan, , Italy

Site Status

Reflux Centre

Birmingham, , United Kingdom

Site Status

Epsom and St. Helier Hospital

Epsom, , United Kingdom

Site Status

Royal Devon & Exeter Hospital

Exeter, , United Kingdom

Site Status

Spire Tunbridge Wells Hospital

Royal Tunbridge Wells, , United Kingdom

Site Status

Weymouth Hospital

Weymouth, , United Kingdom

Site Status

Countries

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Austria Germany Italy United Kingdom

References

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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.

Reference Type DERIVED
PMID: 32676727 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25171881 (View on PubMed)

Other Identifiers

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2776

Identifier Type: -

Identifier Source: org_study_id

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