About this trial
Commonly, in clinical practice an automated analysis of pH-MII tracings is obtained.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 - 80 years old;
pH-MII performed off PPI
Disqualifiers
Prior upper GI endoscopy indicative of structural disease (except for oesophagitis or hiatal hernia).
Incomplete pH-MII (less than 21 hours recording);
Ph-MII performed on PPI
Suboptimal quality of the tracings preventing interpretation in clinical practice;
Trial population
All patients referred for pH-MII are eligible.
Trial design
Case-only
Prospective
Treatments tested in this trial
Questionnaires
Other interventionFSSG \& BEDQ
Treatment groups
Trial outcomes
Primary outcomes
Statistical difference in the GERD categorisation
the statistical difference in the distribution of GERD categorisation between automated vs. manual review of the pH-MII tracings
Secondary outcomes
The analysis of the influence of different parameters on application of the Wingate criteria: including the Indication for referral with further classification into predominant oesophageal and extra-oesophageal symptoms;
The analysis of the influence of different parameters on application of the Wingate criteria: including the GERD Symptom Severity;
The analysis of the influence of different parameters on application of the Wingate criteria: including the patient being on or off PPI;
The analysis of the influence of different parameters on application of the Wingate criteria: including MNBI (obtained by automated analysis or manually calculated);
Sponsors and contacts
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