Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851482
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2023-04-29
Brief Title:
Validation of HRM Score for the GERD Diagnosis
Sponsor:
IRCCS Policlinico S Donato
Organization:
IRCCS Policlinico S Donato
Study Overview
Official Title:
NOVEL HIGH-RESOLUTION MANOMETRY SCORE FOR THE DIAGNOSIS OF GASTRO-ESOPHAGEAL REFLUX DISEASE
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HRM nomogram
Brief Summary:
The goal of this prospective study is to validate a high resolution manometry score to predict pathologic GERD in patients with reflux symptoms The main question it aims to answer is
Is it possible to predict GERD on high resolution manometry Participants will be asked to undergo high resolution manometry and pH-study
Is it possible to predict GERD on high resolution manometry Participants will be asked to undergo high resolution manometry and pH-study
Detailed Description:
According to recent guidelines high resolution manometry HRM has an ancillary role in the diagnosis of gastro-esophageal reflux disease GERD A recent multicenter study demonstrated the effectiveness of the straight leg raise SLR maneuver in predicting GERD thus increasing the diagnostic value of HRM in patients with suspected pathological reflux HRM parameters associated with GERD include esophageal body hypomotility such as ineffective esophageal motility IEM and esophagogastric junction EGJ metrics particularly the EGJ contractile integral EGJ-CI that takes into consideration the presence or absence of a hiatal hernia HH and a hypotensive lower esophageal sphincter LES The combination of these four parameters might help to predict or exclude true GERD in patients undergoing HRM with the suspicion of GERD
In this multicenter international prospective study we aimed to build a score to predict pathological esophageal acid exposure time AET6
In this multicenter international prospective study we aimed to build a score to predict pathological esophageal acid exposure time AET6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None