Registry of Outcomes From AntiReflux Surgery



Status:Recruiting
Conditions:Gastroesophageal Reflux Disease , Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:21 - Any
Updated:3/2/2019
Start Date:May 2016
End Date:May 2025
Contact:Reginald Bell, MD
Email:reg@sofisite.com
Phone:303-788-7700

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Registry of Outcomes From AntiReflux Surgery (ROARS)

Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal
reflux disease and hiatal hernia.

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.

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.
We found this trial at
23
sites
Houston, Texas 77030
Principal Investigator: Patrick Reardon, M.D.
Phone: 346-238-0104
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Steven Bowers, MD
Phone: 904-953-9455
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Albany, Georgia
Phone: 229-434-4200
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1444 South Potomac Street
Aurora, Colorado 80012
Phone: 303-710-0874
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3686 Grandview Parkway
Birmingham, Alabama 35243
Phone: 205-595-8985
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519 Medical Oaks Avenue
Brandon, Florida 33511
Phone: 813-685-7995
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614 Memorial Drive
Chilton, Wisconsin 53014
Principal Investigator: Peter Janu, MD
Phone: 920-849-3800
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3001 Coral Hills Drive
Coral Springs, Florida 33065
Phone: 954-755-0111
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3505 Gaston Avenue
Dallas, Texas 75246
Principal Investigator: F Buckley, MD
Phone: 512-509-4272
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Dallas, Texas 75246
Principal Investigator: Steven G. Leeds, MD, FACS
Phone: 214-820-5283
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Englewood, Colorado 80113
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309 Southridge Parkway
Heber Springs, Arkansas 72543
Phone: 501-250-2020
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1836 South Avenue
La Crosse, Wisconsin 54601
Principal Investigator: Shanu Kothari, MD
Phone: 608-775-2904
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Los Angeles, California 90033
Principal Investigator: John Lipham, MD
Phone: 949-764-1455
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Milwaukee, Wisconsin 53226
Principal Investigator: John Gould, MD
Phone: 414-805-5743
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Mobile, Alabama 36604
Principal Investigator: William Richards, MD
Phone: 251-471-7988
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900 Main Street
Peoria, Illinois 61602
Phone: 309-672-5975
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3801 West 15th Street
Plano, Texas 75075
Phone: 972-519-1348
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519 Medical Oaks Avenue
Riverview, Florida 33578
Phone: 813-685-7995
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Seattle, Washington 98104
Principal Investigator: Brian Louie, MD
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295 Midland Parkway
Summerville, South Carolina 29485
Phone: 843-875-8994
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508 South Habana Avenue
Tampa, Florida 33609
Phone: 813-685-7995
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365 Lennon Lane
Walnut Creek, California 94598
Phone: 925-627-3492
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