A new method for Gastroesophageal Reflux Disease Diagnosis: Signal Detection Theory Approach

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12612000782831
• Lead Sponsor: Marmara University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Patients with heartburn and/or gastric regurgitation

Exclusion Criteria

Gastrointestinal surgery history

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe optimal time window for reflux-symptom relationship analysis. Patients underwent esophageal manometry and 24-hour multichannel intraluminal impedance-pH (MII-pH) monitoring. MII-pH signal data was divided into various consecutive time windows (1, 2, 3, 4, and 5 min) that were evaluated for the presence of reflux and symptom. The SDT parameter (d') values were calculated for each time window. Time window which provides highest d' value was considered as optimal time window.[After proton pomp inhibitor (PPI) responsiveness evaluation.];Find discriminability (d') cut-off points for diagnosis. Receiver Operating Characteristics curve analysis provided these values using with PPI responsive and PPI unresponsive patient d' data.[After proton pomp inhibitor (PPI) responsiveness evaluation.]

Secondary Outcome Measures

Name	Time	Method
Comparison of response bias (c) values between PPI responsive and unresponsive group.Patients underwent esophageal manometry and 24-hour multichannel intraluminal impedance-pH (MII-pH) monitoring. MII-pH signal data was divided into various consecutive time windows (1, 2, 3, 4, and 5 min) that were evaluated for the presence of reflux and symptom. The SDT parameter (c) values were calculated for each time window.[After proton pomp inhibitor (PPI) responsiveness evaluation.]