Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000782831
Ethics application status
Approved
Date submitted
13/07/2012
Date registered
24/07/2012
Date last updated
24/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A new method for Gastroesophageal Reflux Disease Diagnosis: Signal Detection Theory Approach
Scientific title
Signal Detection Theory Approach for Symptom Analysis of Impedance-pH Monitoring Signal Data of Patients with Heartburn and Regurgitation
Secondary ID [1] 280846 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux Disease 286913 0
Condition category
Condition code
Oral and Gastrointestinal 287241 287241 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
24 hour ambulatory impedance-pHmeter monitoring. A thin catheter (diameter 2.1 mm) which have attached a data logger (a walkman-sized portable electronic recording device) passed through a nostril and positioned according to lower esophageal sphincter's upper border. Patients then returned home with instructions to press buttons which are located on the data logger for symptoms, meal intake times and sleeping. They were encouraged to carry out normal daily activities without dietary restrictions. At the completion of the study (that is 24 hour), the catheter is removed and the data logger is uploaded to the computer for analysis.
Intervention code [1] 285271 0
Diagnosis / Prognosis
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287523 0
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.
Timepoint [1] 287523 0
After proton pomp inhibitor (PPI) responsiveness evaluation.
Primary outcome [2] 287532 0
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.
Timepoint [2] 287532 0
After proton pomp inhibitor (PPI) responsiveness evaluation.
Secondary outcome [1] 298316 0
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.
Timepoint [1] 298316 0
After proton pomp inhibitor (PPI) responsiveness evaluation.

Eligibility
Key inclusion criteria
Patients with heartburn and/or gastric regurgitation
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Gastrointestinal surgery history

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 4405 0
Turkey
State/province [1] 4405 0

Funding & Sponsors
Funding source category [1] 285630 0
University
Name [1] 285630 0
Marmara University
Country [1] 285630 0
Turkey
Primary sponsor type
University
Name
Marmara University
Address
Marmara Universitesi Tip Fakultesi
Selimiye M. Tibbiye C. No:38
34668 Haydarpasa - Istanbul
Country
Turkey
Secondary sponsor category [1] 284464 0
None
Name [1] 284464 0
Address [1] 284464 0
Country [1] 284464 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287627 0
Ethical Committee of Marmara University Faculty of Medicine
Ethics committee address [1] 287627 0
Ethics committee country [1] 287627 0
Turkey
Date submitted for ethics approval [1] 287627 0
Approval date [1] 287627 0
07/04/2011
Ethics approval number [1] 287627 0
09.2011.0085

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34436 0
Address 34436 0
Country 34436 0
Phone 34436 0
Fax 34436 0
Email 34436 0
Contact person for public queries
Name 17683 0
Adnan Giral
Address 17683 0
Cumhuriyet cad. 134/10 Izmit Kocaeli
Country 17683 0
Turkey
Phone 17683 0
+90 (216) 657-0606 x 4680
Fax 17683 0
Email 17683 0
[email protected]
Contact person for scientific queries
Name 8611 0
Adnan Giral
Address 8611 0
Cumhuriyet cad. 134/10 Izmit Kocaeli
Country 8611 0
Turkey
Phone 8611 0
+90 (216) 657-0606 x 4680
Fax 8611 0
Email 8611 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.