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Registry of Outcomes From AntiReflux Surgery (ROARS)

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ClinicalTrials.gov Identifier: NCT02923362
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
The Heartburn Foundation

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

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease Hiatal Hernia Procedure: Laparoscopic Fundoplication Device: LINX Antireflux

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Registry of Outcomes From AntiReflux Surgery (ROARS)
Study Start Date : May 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Laparoscopic Fundoplication Group
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
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.
Other Names:
  • Nissen Fundoplication
  • Fundoplication
  • Fundoplasty
  • Hiatal Hernia Repair
  • Partial Fundoplication

LINX Antireflux Device Group
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
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.
Other Names:
  • LINX System
  • LINX Implant
  • LINX Reflux Management System
  • LINX Magnetic Sphincter Augmentation




Primary Outcome Measures :
  1. Quality of Life reported by patient [ Time Frame: 5 Years ]
    Standard GERD Quality of Life Assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female patient over the age of 21 with no maximum age who meet the eligibility for anti reflux and or hiatal hernia repair surgery
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923362


Contacts
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Contact: Reginald Bell, MD 303-788-7700 reg@sofisite.com
Contact: Rachel Heidrick, BSN 303-788-1636 rachel@iersurgery.com

Locations
Show Show 23 study locations
Sponsors and Collaborators
The Heartburn Foundation
Investigators
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Principal Investigator: Reginald Bell, MD The Heartburn Foundation

Additional Information:

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Responsible Party: The Heartburn Foundation
ClinicalTrials.gov Identifier: NCT02923362    
Other Study ID Numbers: THF001
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The Heartburn Foundation:
GERD
Reflux
Acid Reflux
Heartburn
Regurgitation
Laryngopharyngeal Reflux
Hiatal Hernia
LPR
LINX
Magnetic Sphincter Augmentation
Antireflux Surgery
Nissen
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Hernia
Hernia, Hiatal
Pathological Conditions, Anatomical
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hernia, Diaphragmatic