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Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study) (EFRAIM)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Technische Universität München.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01080690
First Posted: March 4, 2010
Last Update Posted: March 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität München
January 27, 2010
March 4, 2010
March 4, 2010
January 2010
June 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Abdominal Pain
  • Procedure: EGD
    In this arm EGD will be performed before EUS.
    Other Names:
    • EGD: A standard diagnostic EGD will be performed.
    • EUS: A standard diagnostic EUS will be performed.
  • Procedure: EUS
    In this arm EUS will be performed before EGD.
  • Active Comparator: EGD
    In this arm EGD will be performed before EUS
    Intervention: Procedure: EGD
  • Active Comparator: EUS
    In this arm, EUS will be performed before EGD.
    Intervention: Procedure: EUS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
240
December 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • acute right side abdominal pain
  • willing participate study

Exclusion Criteria:

  • acute disease
  • malignancy
  • other disease which might cause discomfort
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01080690
01102
No
Not Provided
Not Provided
Prof. A. Meining, TUM, Technical University Munich
Technische Universität München
Not Provided
Principal Investigator: Alexander Meining, Prof. II Med Dep, TU Munich
Technische Universität München
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP