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Gastroesophageal Reflux Disease in Azerbaijan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616119
Recruitment Status : Unknown
Verified August 2019 by Sevda Aghayeva, Azerbaijan Gastroenterology and Hepatology Association.
Recruitment status was:  Active, not recruiting
First Posted : August 6, 2018
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
Azerbaijan Medical University
Information provided by (Responsible Party):
Sevda Aghayeva, Azerbaijan Gastroenterology and Hepatology Association

Study Description
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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.

Condition or disease
Gastroesophageal Reflux Disease

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Prevalence of Gastroesophageal Reflux Disease in Azerbaijan
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. GER questionnaire (GERQ) of Mayo case 1998- 019 [ Time Frame: 1 year ]
    Observational study


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18-80 age range
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616119


Locations
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Azerbaijan
Azerbaijan Gastroenterology and hepatology Association
Baku, Nasimi, Azerbaijan, AZ1018
Sponsors and Collaborators
Sevda Aghayeva
Azerbaijan Medical University
Investigators
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Principal Investigator: Sevda Aghayeva, MD Azerbaijan Gastroenterology and Hepatology Association
More Information
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Additional Information:

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Responsible Party: Sevda Aghayeva, principal investigator, Azerbaijan Gastroenterology and Hepatology Association
ClinicalTrials.gov Identifier: NCT03616119    
Other Study ID Numbers: QastroHep
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sevda Aghayeva, Azerbaijan Gastroenterology and Hepatology Association:
gastoesophageal reflux disease
prevalence
Azerbaijan
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases