Gastroesophageal Reflux Disease in Azerbaijan

December 11, 2022 updated by: Sevda Aghayeva

The Prevalence of Gastroesophageal Reflux Disease in Azerbaijan

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Azerbaijan
    • Nasimi
      • Baku, Nasimi, Azerbaijan, AZ1018
        • Azerbaijan Gastroenterology and hepatology Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Azerbaijan is divided by clusters with a definite numbers of individuals to take survey on reflux disease in the given age range and calculated by proportion of males and females.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year
GERD questionnaire (GERD) of Mayo case 1998- 019
Time Frame: 1 year
Observational study
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sevda Aghayeva

Collaborators

Azerbaijan Medical University

Investigators

  • Principal Investigator: Sevda Aghayeva, MD, Azerbaijan Gastroenterology and hepatology Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

July 29, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 6, 2018

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 11, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QastroHep

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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