Gastroesophageal Reflux Disease in Azerbaijan

Completed

• Conditions: Gastroesophageal Reflux Disease

• Registration Number: NCT03616119
• Lead Sponsor: Sevda Aghayeva

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 Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-07-29
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-06
• Primary Completion: 2019-08-01
• Study Completion: 2019-09-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-11
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Age: 18-80
• Both genders
• Hearburn
• Belching
• Regurgitation

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of GERD in Azerbaijan	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	1 year	Observational study

Trial Locations

Locations (1)

Azerbaijan Gastroenterology and hepatology Association; 🇦🇿 Baku, Nasimi, Azerbaijan