The Clinical Significance of Minimal Change in Reflux Esophagitis Based on the Gastroesophageal Reflux Disease Questionnaire

Non-interventional, Cross-sectional, Multi-center Study to Establish The Clinical Significance of Minimal Change in Reflux Esophagitis Based on the Gastroesophageal Reflux Disease Questionnaire (GerdQ)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00901004

Acronym

MIGHT

Enrollment

1550

Registered

2009-05-13

Start date

2009-04-30

Completion date

2009-09-30

Last updated

2010-12-07

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

Conditions

Gastroesophageal Reflux Disease

Keywords

Minimal Change, GERD, GERDQ

Brief summary

The purpose of this study is to define the endoscopic findings of minimal change that is significant to clinical significant reflux esophagitis. Through this, the investigators want to estimate the applicability of minimal change findings of reflux esophagitis to the clinic.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 20 years old patients who consent to revealing their medical information and be able to respond to questionnaires regarding the symptom. * Patients who had shown the reflux esophageal minimal change in the endoscopic finding: the reflux esophagitis

Exclusion criteria

* Patients who had shown the mucosal break or barrett esophagus at gastric mucosal barrier or lower oesophagus in endoscopic findings * Patient with a diagnosis of gastroesophageal reflux disease and who have received medication treatment * Patient who had received H2-receptor antagonists, prostaglandin, PPI, NSAIDs or aspirin, high dose steroid and anticoagulants for at least 5 consecutive days in the 4-week period immediately preceding the diagnostic endoscopy * Patients with a history of operation due to gastrointestinal disease, malignancy, alcoholism, pregnancy (in female), breast feeding (in female) or systemic disease

Design outcomes

Primary

Measure	Time frame
To investigate significant minimal change endoscopic finding of reflux esophagitis diagnosis	Significant minimal change endoscopic finding for gastroesophageal reflux disease diagnosis

Secondary

Measure	Time frame
To establish the probability model of diagnosing gastroesophageal reflux disease based on minimal change endoscopic findings through definition of significant minimal change endoscopic findings of gastroesophageal reflux disease diagnosis.	at baseline -->this is a cross-sectional study

Countries

South Korea

Outcome results