Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Commonly, in clinical practice an automated analysis of pH-MII tracings is obtained.
All pH-MII performed in UZ Brussel are already reviewed manually according to the Wingate con-sensus and interpreted according to the Lyon consensus. In this study, we will prospectively categorise the reasons for discarding reflux episodes identified by automated analysis during the manual review according to the Wingate consensus, as well as the impact on different parameters related to the interpretation of pH-MII. Based on comments received to our retrospective study, we will evaluate possible confounders to the interpretation, including the indication for referral for pH-MII, symptom severity, use of PPI during pH-MII.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GERD patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | FSSG & BEDQ |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | During baseline visit | |
| The analysis of the influence of different parameters on application of the Wingate criteria: including the GERD Symptom Severity; |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
All patients referred for pH-MII are eligible.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sébastien Kindt, Prof. Dr. | Contact | +32 2 477 | 60 11 | sebastien.kindt@uzbrussel.be |
| Virgini Van Buggenhout | Contact | +32 2 477 | 60 11 | virgini.vanbuggenhout@uzbrussel.be |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H.U.B | Recruiting | Anderlecht | 1080 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| During baseline visit |
| The analysis of the influence of different parameters on application of the Wingate criteria: including the patient being on or off PPI; | During baseline visit |
| The analysis of the influence of different parameters on application of the Wingate criteria: including MNBI (obtained by automated analysis or manually calculated); | During baseline visit |
| Presence of significant correlations between censored episodes and pH-MII parameters | Correlations including:
| During baseline visit |
| Impact of the Wingate criteria on The number of PSPW; | During baseline visit |
| Impact of the Wingate criteria on The number of symptoms associated with an impedance episode. | During baseline visit |
| Impact of the Wingate criteria on the number of impedance episodes with or without acidic reflux | During baseline visit |
| UZ Brussel | Recruiting | Jette | 1090 | Belgium |
|
| Technische Universität München | Recruiting | München | 81675 | Germany |
|
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided