NIPH Clinical Trials Search

A Study on the Diagnostic Accuracy of Hiatal Hernias Using the New E Scale Symptom Assessment Tool

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Hiatal hernia
Date of first enrollment	25/05/2026
Target sample size	150
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome	E-Scale Total Score
Secondary Outcome	E-Scale Typical Symptom Score and Atypical Symptom Score

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients suspected of having a hiatal hernia who continue to experience reflux symptoms or upper abdominal symptoms despite taking P-CAB or PPI at standard doses for 4 to 8 weeks. Patients whose status regarding hiatal hernia has been determined via endoscopy at Minami-Osaka Hospital. For prospective studies, obtaining an E-scale score prior to endoscopy is mandatory.
Exclude criteria	Patients with a history of hiatal hernia surgery. Patients with a history of upper gastrointestinal resection or vagotomy. Patients exhibiting warning signs (vomiting, hematemesis or melena, anemia, or sudden weight loss) and suspected of having a malignant disease. Patients in whom malignant lesions have been confirmed by endoscopy or other examinations. Patients with concomitant irritable bowel syndrome. Patients deemed unsuitable for study participation due to severe concomitant liver, kidney, or heart disease, etc. Pregnant women, lactating women, or women who may be pregnant. Patients for whom obtaining an E-scale is difficult. Patients for whom participation in this study is deemed difficult by the principal investigator or attending physician.