Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study) (EFRAIM)
Recruitment status was: Recruiting
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:||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 ]
|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)|
Active Comparator: EGD
In this arm EGD will be performed before EUS
In this arm EGD will be performed before EUS.
Active Comparator: EUS
In this arm, EUS will be performed before EGD.
In this arm EUS will be performed before EGD.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080690
|Klinikum r.d. Isar, Technical University Munich|
|Principal Investigator:||Alexander Meining, Prof.||II Med Dep, TU Munich|