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

Use our guide to learn which trials are right for you!

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
614 Memorial Drive
Chilton, Wisconsin 53014
Principal Investigator: Peter Janu, MD
Phone: 920-849-3800
?
mi
from
Chilton, WI
Click here to add this to my saved trials
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...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Albany, Georgia
Phone: 229-434-4200
?
mi
from
Albany, GA
Click here to add this to my saved trials
1444 South Potomac Street
Aurora, Colorado 80012
Phone: 303-710-0874
?
mi
from
Aurora, CO
Click here to add this to my saved trials
3686 Grandview Parkway
Birmingham, Alabama 35243
Phone: 205-595-8985
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
519 Medical Oaks Avenue
Brandon, Florida 33511
Phone: 813-685-7995
?
mi
from
Brandon, FL
Click here to add this to my saved trials
3001 Coral Hills Drive
Coral Springs, Florida 33065
Phone: 954-755-0111
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials
3505 Gaston Avenue
Dallas, Texas 75246
Principal Investigator: F Buckley, MD
Phone: 512-509-4272
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75246
Principal Investigator: Steven G. Leeds, MD, FACS
Phone: 214-820-5283
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Englewood, Colorado 80113
?
mi
from
Englewood, CO
Click here to add this to my saved trials
309 Southridge Parkway
Heber Springs, Arkansas 72543
Phone: 501-250-2020
?
mi
from
Heber Springs, AR
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Patrick Reardon, M.D.
Phone: 346-238-0104
?
mi
from
Houston, TX
Click here to add this to my saved trials
1836 South Avenue
La Crosse, Wisconsin 54601
Principal Investigator: Shanu Kothari, MD
Phone: 608-775-2904
?
mi
from
La Crosse, WI
Click here to add this to my saved trials
Los Angeles, California 90033
Principal Investigator: John Lipham, MD
Phone: 949-764-1455
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Milwaukee, Wisconsin 53226
Principal Investigator: John Gould, MD
Phone: 414-805-5743
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Mobile, Alabama 36604
Principal Investigator: William Richards, MD
Phone: 251-471-7988
?
mi
from
Mobile, AL
Click here to add this to my saved trials
900 Main Street
Peoria, Illinois 61602
Phone: 309-672-5975
?
mi
from
Peoria, IL
Click here to add this to my saved trials
3801 West 15th Street
Plano, Texas 75075
Phone: 972-519-1348
?
mi
from
Plano, TX
Click here to add this to my saved trials
519 Medical Oaks Avenue
Riverview, Florida 33578
Phone: 813-685-7995
?
mi
from
Riverview, FL
Click here to add this to my saved trials
Seattle, Washington 98104
Principal Investigator: Brian Louie, MD
?
mi
from
Seattle, WA
Click here to add this to my saved trials
295 Midland Parkway
Summerville, South Carolina 29485
Phone: 843-875-8994
?
mi
from
Summerville, SC
Click here to add this to my saved trials
508 South Habana Avenue
Tampa, Florida 33609
Phone: 813-685-7995
?
mi
from
Tampa, FL
Click here to add this to my saved trials
365 Lennon Lane
Walnut Creek, California 94598
Phone: 925-627-3492
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials