Reproducibility of provocative tests during esophageal high-resolution manometry

Reproducibility of provocative tests during esophageal high-resolution manometry - REPRO

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53367

Enrollment

Registered

2023-07-05

Start date

2023-10-31

Completion date

Unknown

Last updated

2024-09-23

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

Conditions

dysphagia esophageal motility disorder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Complaints of dysphagia and/or reflux; • Age of 18 years or older; • High-resolution manometry as part of routine clinical practice; • Written informed consent;

Exclusion criteria

Exclusion criteria: • (Suspect) esophageal motility disorder for which treatment is scheduled between the two manometry measurements; • Use of medication which affect gastrointestinal motility that cannot be stopped (e.g. prokinetics or opioids); • Another explanation for their dysphagia complaint on previous upper endoscopy (within three years); • Previous gastroesophageal surgery (e.g. bariatrics or fundoplication); • Coeliac disease; • Insufficient Dutch or English language skills to understand information about the measurement.

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the reproducibility of provocative tests during high-resolution manometry. The reproducibility is determined by concordance of normal and abnormal outcomes of each provocative test.	—

Secondary

Measure	Time frame
• Reproducibility of single wet swallows determined by concordance of normal and abnormal outcomes. • Agreement of outcome variables between first and second measurement within one test determined by intraclass correlation coefficient (ICC) • Change in diagnosis of esophageal motility disorder after second measurement • Agreement of different outcome variables between single wet swallows and provocative tests.	—

Measure

Time frame

• Reproducibility of single wet swallows determined by concordance of normal and abnormal outcomes. • Agreement of outcome variables between first and second measurement within one test determined by intraclass correlation coefficient (ICC) • Change in diagnosis of esophageal motility disorder after second measurement • Agreement of different outcome variables between single wet swallows and provocative tests.

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Countries

Netherlands

Outcome results