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

A Study on the Diagnostic Accuracy of Hiatal Hernia and the Determination of Surgical Indications Using the New E-Scale (Epigastric and Esophageal Symptom Scale: EESS): Development and Validation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1050260057
Enrollment
150
Registered
2026-05-25
Start date
2026-05-25
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Hiatal hernia Hiatal hernia

Interventions

None listed

Sponsors

Masashi Takemura
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
E-Scale Total Score

Secondary

MeasureTime frame
E-Scale Typical Symptom Score and Atypical Symptom Score

Contacts

Public ContactRyoichi Nishiki

Keigaku-Kai Social Medical Corporation Minami Osaka Hospital

ryoichi_nishiki@minamiosaka.com+81-6-6685-0221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026