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Clinical Trials/NCT03616119
NCT03616119CompletedNot Applicable

The Prevalence of Gastroesophageal Reflux Disease in Azerbaijan

Sevda Aghayeva1 site in 1 country1,000 target enrollmentStarted: January 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,000
Locations
1
Primary Endpoint
The prevalence of GERD in Azerbaijan

Study Overview

Brief Summary

To evaluate the prevalence of Gastroesophageal reflux disease in Azerbaijan. It is intended to evaluate the prevalence of the disease in the regions as well as the capital by cluster sampling ,ethitology and to compare the outcomes depending on the geographical location.

Detailed Description

It is an observational, nationwide study. The GERD questionnaire (1994) requested from Mayo clinic, was received and validated. The questionnaire was translated by 3 individuals from english to azeri and back trasnlated by 3 native english speakers.

Power analysis was performed. The research was presented for the approval to Ethical Committee of Azerbaijan Medical University.

Prior to the actual study, a pilot study with smaller number of participants was performed and the results were evaluated.

Cluster sampling methodology was provided by the statistical department of Azerbaijan Medical University.

110 employees were hired for using a survey in different regions of Azerbaijan. Written consent was obtained from every person evaluated. Statistical ananlysis was performed.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age: 18-80
  • Both genders
  • Regurgitation

Exclusion Criteria

  • protom pomp inhibitor use
  • antibiotic use in the last 4 weeks
  • upper GI surgery

Outcomes

Primary Outcomes

The prevalence of GERD in Azerbaijan

Time Frame: 1 year

The prevalence of GERD in Azerbaijan was 22.7% with significant female predominance (26.1% vs 15.3%; p\<0.0001). GERD was defined in 17 % for ages below 35; 22.7 % for 36-55 and 38.5 % for those who are above 56 that, accordingly, indicating that GERD becomes significant as age increases (p\<0.0001). Reflux was observed in 18.1% of normal weight respondents (BMI 18.6-24.9), 25.6% of overweight (BMI 25-29.9), and in 30.4% of obese (BMI\>30) individuals (p=0.001). Regarding marital status, the prevalence was the lowest in the single subjects' group (17%), close to average in the married group (23.8%), and the highest (41.7%) in divorced/widowed cases (p=0.003). Stress was significantly affecting GERD distribution, affecting 59.4% of all respondents (p\<0.004).

GERD questionnaire (GERD) of Mayo case 1998- 019

Time Frame: 1 year

Observational study

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sevda Aghayeva
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Sevda Aghayeva

principal investigator

Azerbaijan Gastroenterology and Hepatology Association

Study Sites (1)

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