The Use of International GerdQ Questionnaire
Completed
- Conditions
- Gastroesophageal Reflux Disease
- Registration Number
- NCT01489735
- Lead Sponsor
- AstraZeneca
- Brief Summary
There are three main directions for use GerdQ in practice. First of all, GerdQ can be used to diagnose GERD with an accuracy comparable to the accuracy of diagnosis of GERD by the specialist (gastroenterologist). Using GerdQ can evaluate the impact of disease on the patient's life and help in choosing treatment of GERD, as well as direct assessment of treatment efficacy.
In connection with mentioned above, this study is devoted to the estimation of possibility to use GerdQ in routine practice of Russian physicians.
- Detailed Description
Observational non-interventional study on the use of international GerdQ questionnaire for the diagnosis of gastroesophageal reflux disease in the Russian practice
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Signing of informed consent to participate in the study
- patients of both sexes, 18 years and older
- planned esophagogastroduodenoscopy
Exclusion Criteria
- Surgical intervention for upper digestive tract (surgery for gastroesophageal reflux disease, peptic ulcer disease, etc.) In the past
- the presence of contraindications for esophagogastroduodenoscopy or pH-metry
- refusal to sign informed consent
- acceptance of antisecretory drugs (proton pump inhibitors, h2-receptor blockers), antacids and prokinetics for 7 days before enrollment
- Pregnancy
- Confirmed or suspected malignancy
- Impairment of the mental sphere
- Acceptance of nsaids (including acetylsalicylic acid at a dose of 150 mg / day), cytostatics, antibiotics (tetracyclines, lincosamides) at enrollment and during the preceding 30 days
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score ≥8) / number of patients whose GERD was confirmed by instrumental examinations. Up to 6 months Specificity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score <8) / number of patients whose GERD diagnosis was excluded on the basis of instrumental examination Up to 6 months
- Secondary Outcome Measures
Name Time Method Sensitivity of GERD diagnosis made by gastroenterologist = result of completion of GerdQ questionnaire / the results of clinical assessment by gastroenterologist. Up to 6 months Frequency of GERD diagnosis based on instrumental examination (endoscopy, pH-metry) in studied patients. Up to 6 months Prevalence of GERD with the completed GerdQ questionnaire, which corresponds to the proportion (%) of patients with a total score of ≥ 8 in the questionnaire, among study patients. Up to 6 months
Trial Locations
- Locations (1)
Research site
🇷🇺Moscow, Russian Federation