Registry of Outcomes From AntiReflux Surgery

Study Overview
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Brief Summary
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Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.

Detailed Description
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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.

Official Title
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Registry of Outcomes From AntiReflux Surgery (ROARS)

Conditions
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Gastroesophageal Reflux Disease, Hiatal Hernia

Intervention / Treatment
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* Procedure: Laparoscopic Fundoplication
* Device: LINX Antireflux


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic Fundoplication Group<br>This group of patients are surgical candidates based on preoperative testing results for laparoscopic fundoplication antireflux procedure and possible hiatal hernia repair. | Procedure: Laparoscopic Fundoplication<br>* The gastric fundus of the stomach is wrapped or plicated around the lower end of the esophagus and and stitched in place reinforcing the closing function of the lower esophageal sphincter. The hiatus is also narrowed down with sutures or mesh to prevent or treat a concurrent hiatal hernia.<br>* Other names: Partial Fundoplication;|
| LINX Antireflux Device Group<br>This group of patients are surgical candidates based on preoperative testing results for the laparoscopic LINX antireflux device placement and possible hiatal hernia repair. | Device: LINX Antireflux<br>* The LINX is a flexible band of interlocked titanium beads with a magnetic core. The LINX is placed around the lower esophageal sphincter to help restore the function of the LES by preventing reflux into the esophagus.<br>* Other names: LINX Magnetic Sphincter Augmentation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life reported by patient | Standard GERD Quality of Life Assessment | 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Reflux, Acid Reflux, Heartburn, Regurgitation, Laryngopharyngeal Reflux, Hiatal Hernia, LPR, LINX, Magnetic Sphincter Augmentation, Antireflux Surgery, Nissen