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
|Condition or disease||Intervention/treatment|
|Gastroesophageal Reflux Disease Hiatal Hernia||Procedure: Laparoscopic Fundoplication Device: LINX Antireflux|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2500 participants|
|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|
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.
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.
- Quality of Life reported by patient [ Time Frame: 5 Years ]Standard GERD Quality of Life Assessment
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
|Contact: Reginald Bell, MDfirstname.lastname@example.org|
|Contact: Rachel Heidrick, BSNemail@example.com|
|Principal Investigator:||Reginald Bell, MD||The Heartburn Foundation|