Investigating the effect of anti-reflux mucosal ablation (ARMA) in reducing the symptoms of esophageal reflux (GERD) in patients resistant to treatment with proton pump inhibitors (PPI)
Not Applicable
- Conditions
- Gastroesophageal reflux disease.Gastro-esophageal reflux disease without esophagitisK21.9
- Registration Number
- IRCT20200217046520N2
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Age between 20 and 65 years
At least one typical symptom of reflux more than twice a week
Sliding hiatal hernia
Hill grade minimum I and maximum III
Exclusion Criteria
Pregnancy
Primary motility disorders of the esophagus
Hiatal hernia sliding more than 3 cm
Hill grade IV
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The reduction of reflux symptoms in gastroesophageal reflux disease-related quality of life questionnaire (GERD-HRQL) and the frequency of gastroesophageal reflux disease symptoms (FSSG). Timepoint: Measurement of patients' symptoms based on questionnaires at the beginning of the study (before the start of the intervention) and 1 and 3 months after anti reflux mucosal ablation. Method of measurement: Gastroesophageal reflux disease-related quality of life questionnaire (GERD-HRQL), assessment of the frequency of gastroesophageal reflux disease symptoms (FSSG), upper endoscopy.
- Secondary Outcome Measures
Name Time Method