N/A
N=760
Observational Study of Anti-Reflux Surgery
GERD · Gastroesophageal Reflux · Gastro Esophageal Reflux
Bottom Line
View on ClinicalTrials.gov: NCT01624506 ↗Enrolled (actual)
760
Serious AEs
3.4%
Results posted
Jun 2021
Primary outcome: Primary: Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL) — 4.2; 4.9 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Torax Medical Incorporated
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL) |
4.2; 4.9 | — |
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
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01624506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.