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The Anti-Reflux Surgical Study has been established to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Sphincter Augmentation | Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System | ||
| Fundoplication | Patients treated with laparoscopic fundoplication |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing antireflux surgery for the treatment of gastroesophageal reflux disease (GERD)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH Wien | Vienna | Austria | ||||
| Herz Jesu Krankenhaus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32676727 | Derived | 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. | |
| 25171881 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Magnetic Sphincter Augmentation | Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System |
| FG001 | Fundoplication | Patients treated with laparoscopic fundoplication |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnetic Sphincter Augmentation | Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System |
| BG001 | Fundoplication | Patients treated with laparoscopic fundoplication |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data not available for remaining subjects | Mean | Standard Deviation | years |
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| Sex: Female, Male | Data not available for remaining subjects | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Years with Gastroesophageal Reflux Disease (GERD) | Data not available for remaining subjects | Mean | Standard Deviation | years |
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| Years with Proton Pump Inhibitors (PPI) | Data not collected for remaining subjects | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Enrolled subjects who completed the 3-year visit and responded to the Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL) questionnaire are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 3 years post-surgery |
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3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magnetic Sphincter Augmentation | Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System | 1 | 530 | 22 | 530 | 98 | 530 |
| EG001 | Fundoplication | Patients treated with laparoscopic fundoplication | 0 | 230 | 4 | 230 | 30 | 230 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device erosion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Gatric pain | Gastrointestinal disorders | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Worsening of GERD | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet DeMarchi | Ethicon | 612-867-8727 | jdemarch@its.jnj.com |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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