Ignite Creation Date:
2024-05-06 @ 3:09 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02211105
Status:
TERMINATED
Last Update Posted:
2018-01-09
First Post:
2014-08-05
Brief Title:
Registry to Compare Two Surgical Treatments for GERD
Sponsor:
American Gastroenterological Association
Organization:
American Gastroenterological Association
Study Overview
Official Title:
Laparoscopic Nissen Fundoplication LNF Surgery Versus Transoral Incisionless Fundoplication TIF Anti- Reflux Treatment Registry
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unexpected low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR Registry
Brief Summary:
The purpose of this prospective observational research study registry is to examine whether two GERD surgeries Laparoscopic Nissen Fundoplication LNF or Transoral Incisionless Fundoplication TIF have similar outcomes in effectiveness safety post-operative side effects and post-procedure costs associated with episodes of care and any ensuing complications
Detailed Description:
This registry will prospectively enroll 500 patients undergoing TIF and LNF from approximately 20 United States centers proficient in these procedures that have provided informed consent for the above mentioned data collection symptom questionnaires medical treatments complications side-effects and costs The observational registry will obtain the patients clinical data related to gastrointestinal symptoms for three years post-consent
At baseline and for a three-year period following a clinically indicated TIF or LNF procedure data will be obtained from phone calls andor during office-visits made at specified intervals During these data collection periods patients will be asked to complete standard validated symptom questionnaires as well as report on episodes of care related to their procedures along with financial costs of care
At baseline and for a three-year period following a clinically indicated TIF or LNF procedure data will be obtained from phone calls andor during office-visits made at specified intervals During these data collection periods patients will be asked to complete standard validated symptom questionnaires as well as report on episodes of care related to their procedures along with financial costs of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None