Registry of Outcomes From AntiReflux Surgery
- Conditions
- Hiatal HerniaGastroesophageal Reflux Disease
- Interventions
- Procedure: Laparoscopic FundoplicationDevice: LINX Antireflux
- Registration Number
- NCT02923362
- Lead Sponsor
- The Heartburn Foundation
- Brief Summary
Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.
- Detailed Description
This is a prospective, multi center, observational database of patients that are having surgical laparoscopic antireflux procedure and/or hiatal hernia repair, including laparoscopic Nissen fundoplication and Magnetic Sphincter Augmentation with the LINX device. Patients meeting registry inclusion and exclusion will be followed for 5 years with standardized quality of life surveys and appropriate standard of care testing. Up to 40 sites will participate with total enrollment of 1000 patients.
The main objectives are to collect data from everyday clinical practices and track patients from preoperative assessments to 5 years post surgical intervention to evaluate symptoms, medication use and side effects.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2500
- Subject must be at least 21years of age and at least the minimum Age of Majority according to applicable state law.
- Subject is a suitable surgical candidate, i.e. is able to undergo appropriate anesthesia and endoscopic procedure or laparoscopic surgery.
- Appropriate indications for and documentation of disease process requiring surgery. (Documented gastroesophageal reflux disease by accepted endoscopic or ambulatory reflux monitoring criteria, or have a hiatal hernia that meets accepted criteria for repair (e.g. large paraesophageal hernia with chest pain)).
- Subject is willing and able to cooperate with follow-up examinations
- Subject has been informed of the study procedures and treatment and has signed an informed consent for the study.
- Suspected or confirmed esophageal or gastric cancer.
- Cannot understand trial requirements or is unable to comply with follow-up schedule
- Pregnant or nursing, or plans to become pregnant during the course of the study
- Medical illness (i.e. congestive heart failure) that may cause the subject to be non-compliant with or able to meet the protocol requirements or is associated with limited life expectancy (i.e. less than 3 years)
- Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Laparoscopic Fundoplication Group Laparoscopic Fundoplication This group of patients are surgical candidates based on preoperative testing results for laparoscopic fundoplication antireflux procedure and possible hiatal hernia repair. LINX Antireflux Device Group LINX Antireflux This group of patients are surgical candidates based on preoperative testing results for the laparoscopic LINX antireflux device placement and possible hiatal hernia repair.
- Primary Outcome Measures
Name Time Method Quality of Life reported by patient 5 Years Standard GERD Quality of Life Assessment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Affinity Medical Group
🇺🇸Chilton, Wisconsin, United States
University of Southern Alabama
🇺🇸Mobile, Alabama, United States
Institute of Esophageal and Reflux Surgery
🇺🇸Englewood, Colorado, United States
North Texas Surgical Oncology Associates
🇺🇸Plano, Texas, United States
Swedish Health Services
🇺🇸Seattle, Washington, United States
The Arkansas Heartburn Treatment Center
🇺🇸Heber Springs, Arkansas, United States
Bass Medical Group
🇺🇸Walnut Creek, California, United States
HealthOne Cardiothoracic Surgery Associates
🇺🇸Aurora, Colorado, United States
South Florida Surgical Specialists, LLC
🇺🇸Coral Springs, Florida, United States
Suncoast Surgical Associates
🇺🇸Brandon, Florida, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Baylor Scott and White Research Institute
🇺🇸Dallas, Texas, United States
Tampa Bay Reflux Center
🇺🇸Riverview, Florida, United States
The Tampa Bay Reflux Center
🇺🇸Tampa, Florida, United States
Coastal Carolina Bariatric and Surgical Center
🇺🇸Summerville, South Carolina, United States
Baylor University Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Houston Methodist Research Institute
🇺🇸Houston, Texas, United States
Advanced Surgeons, PC
🇺🇸Birmingham, Alabama, United States
Froedtert & The Medical College of Wisconsin Hospitals and Health Partners
🇺🇸Milwaukee, Wisconsin, United States