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Multivariate analysis of predictors for severity of mucosal lesions in patients with gastro-oesophageal reflux symptoms: a clinical, epidemiological and endoscopic survey

Multivariate analysis of predictors for severity of mucosal lesions in patients with gastro-oesophageal reflux symptoms: a clinical, epidemiological and endoscopic survey

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12609000045213
Enrollment
400
Registered
2009-01-20
Start date
2006-06-20
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Clinical observations suggest that the endoscopic grade of reflux oesophagitis varies significantly in patients presenting in two different hospitals A and B. These Hospitals are located in socioeconomic diverse areas, which has a big impact in health care utilization and patient’s follow-up. But this difference and a reason have not been studied prospectively so far. This is an epidemiological study using questionnaires for patients with symptoms Gastro-oesophageal Reflux Disease such as heartburn and regurgitation. Symptomatic patients referred for endoscopy will be asked complete the surveys providing information of their gastointestinal symptoms, psychological and emotional status, lifestyle and sociodemographics. Surveys are mailed in the post at time points zero, 2 months and 6 months. The aim is to assess patient’s outcome in a routine clinical care setting in a follow-up over 6 months. We like to determine possible predictors of response/non-response, symptom improvement and efficacy of the common treatment with proton pump inhibitors.

Interventions

Epidemiological study using the Bowel Disease Questionnaire, the Nepean Dyspepsia Index, the Hospital Anxiety and Depression Score, the Patient Assessment of Upper Gastrointestinal Symptom Severity Index, and the ReQuest Patient Diary. The Patient will complete the surveys providing information of their gastointestinal symptoms, psychological and emotional status, lifestyle and sociodemographics. Surveys are mailed in the post at time points zero, 2 months and 6 months.

Sponsors

Nycomed GmbH (prior Altana Pharma)
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

primary complaints are reflux symptoms (heartburn, regurgitation)

Exclusion criteria

patients with significant co-morbidities, poor surgical candidate, unstable psychiatric disorder, unable to sign consent and complete questionnaires.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026