Gastroesophageal Reflux, Gastro Esophageal Reflux, GERD
Conditions
Keywords
Gastroesophageal Reflux Disease, Fundoplication, Magnetic Sphincter Augmentation, Proton Pump Inhibitors, GERD, PPI, MSA
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.
Interventions
None listed
Sponsors
Torax Medical Incorporated
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Austria, Germany, Italy, United Kingdom
Participant flow
Pre-assignment details
Not required
Participants by arm
| Arm | Count |
|---|---|
| Magnetic Sphincter Augmentation Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System | 530 |
| Fundoplication Patients treated with laparoscopic fundoplication | 230 |
| Total | 760 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Death | 1 | 0 |
| Overall Study | LINX explants | 23 | 0 |
| Overall Study | Lost to Follow-up | 29 | 15 |
| Overall Study | Withdrawal by Subject | 9 | 2 |
Baseline characteristics
| Characteristic | Magnetic Sphincter Augmentation | Fundoplication | Total |
|---|---|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 13.7 | 55.8 years STANDARD_DEVIATION 12.1 | 49.4 years STANDARD_DEVIATION 13.9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Austria | 27 participants | 34 participants | 61 participants |
| Region of Enrollment Germany | 298 participants | 133 participants | 431 participants |
| Region of Enrollment Italy | 104 participants | 37 participants | 141 participants |
| Region of Enrollment United Kingdom | 101 participants | 26 participants | 127 participants |
| Sex: Female, Male Female | 198 Participants | 113 Participants | 311 Participants |
| Sex: Female, Male Male | 321 Participants | 102 Participants | 423 Participants |
| Years with Gastroesophageal Reflux Disease (GERD) | 9.0 years STANDARD_DEVIATION 7.9 | 8.9 years STANDARD_DEVIATION 8.1 | 9.0 years STANDARD_DEVIATION 7.9 |
| Years with Proton Pump Inhibitors (PPI) | 6.1 years STANDARD_DEVIATION 5.4 | 5.8 years STANDARD_DEVIATION 5.7 | 6.0 years STANDARD_DEVIATION 5.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 530 | 0 / 230 |
| other Total, other adverse events | 98 / 530 | 30 / 230 |
| serious Total, serious adverse events | 22 / 530 | 4 / 230 |
Outcome results
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
Time frame: 3 years post-surgery
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnetic Sphincter Augmentation | Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL) | 4.2 score on a scale | Standard Deviation 5.7 |
| Fundoplication | Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL) | 4.9 score on a scale | Standard Deviation 7.8 |