Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Abdominal Pain |
Procedure: EGD Procedure: EUS |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic |
| Official Title: | Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study) |
- 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 ] [ Designated as safety issue: Yes ]
- Calculate the time and cost savings and number of procedures for endosonography alone versus the combined approach of abd. sonography, gastroscopy and endosonography. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 240 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: EGD
In this arm EGD will be performed before EUS
|
Procedure: EGD
In this arm EGD will be performed before EUS.
Other Names:
|
|
Active Comparator: EUS
In this arm, EUS will be performed before EGD.
|
Procedure: EUS
In this arm EUS will be performed before EGD.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Valentin Becker, Dr. | +49 89 41400 | valentin.becker@lrz.tum.de |
| Germany | |
| Klinikum r.d. Isar, Technical University Munich | Recruiting |
| Munich, Germany | |
| Contact: Alexander Meining, Prof. +49 89 41400 valentin.becker@lrz.tum.de | |
| Principal Investigator: | Alexander Meining, Prof. | II Med Dep, TU Munich |
More Information
No publications provided
| Responsible Party: | Prof. A. Meining, TUM, Technical University Munich |
| ClinicalTrials.gov Identifier: | NCT01080690 History of Changes |
| Other Study ID Numbers: | 01102 |
| Study First Received: | January 27, 2010 |
| Last Updated: | March 3, 2010 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Technische Universität München:
|
endosonography, right side abdominal pain Endosonography (diagnostic value in right side abdominal pain) |
Additional relevant MeSH terms:
|
Abdominal Pain Pain Signs and Symptoms Signs and Symptoms, Digestive |
ClinicalTrials.gov processed this record on June 18, 2013