Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.
Study Overview
Brief Summary
Hypothesis: Endosonography (EUS) in a single setting is equivalent to the standard algorithm combining abdominal sonography, gastroscopy, endosonography in patients with acute right side abdominal pain.
Patients with acute right side abdominal pain will be randomized in one of two groups. In each group all examinations (sonography, gastroscopy, endosonography) will be performed. The study group only defines the order of the examinations. Abdominal sonography will always be performed before endoscopic procedures. In group 1, gastroscopy is first followed by endosonography. In group 2 endosonography is first followed by gastroscopy.
Two physicians will review all results of all examinations, patient charts as well as a follow up visit and establish a clinical diagnosis.
Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •acute right side abdominal pain
- •willing participate study
Exclusion Criteria
- •acute disease
- •malignancy
- •other disease which might cause discomfort
Outcomes
Primary Outcomes
Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.
Time Frame: within the first week of complaints
Secondary Outcomes
- Calculate the time and cost savings and number of procedures for endosonography alone versus the combined approach of abd. sonography, gastroscopy and endosonography.(one year)