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

Sponsor
Technische Universität München (Other)
Overall Status
Unknown status
CT.gov ID
NCT01080690
Collaborator
(none)
240
Enrollment
1
Location
2
Arms
11
Duration (Months)
21.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: EGD
  • Procedure: EUS
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Diagnostic
Official Title:
Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
Study Start Date :
Jan 1, 2010
Anticipated Primary Completion Date :
Jun 1, 2010
Anticipated Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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:
  • EGD: A standard diagnostic EGD will be performed.
  • EUS: A standard diagnostic EUS will be performed.

    		•
    Active Comparator: EUS

    In this arm, EUS will be performed before EGD.

    Procedure: EUS
    In this arm EUS will be performed before EGD.

    Outcome Measures

    Primary Outcome Measures

    1. Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS. [within the first week of complaints]

    Secondary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinikum r.d. Isar, Technical University Munich Munich Germany

    Sponsors and Collaborators

    • Technische Universität München

    Investigators

    • Principal Investigator: Alexander Meining, Prof., II Med Dep, TU Munich

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01080690
    Other Study ID Numbers:
    • 01102
    First Posted:
    Mar 4, 2010
    Last Update Posted:
    Mar 4, 2010
    Last Verified:
    Feb 1, 2010
    Keywords provided by , ,
    endosonography, right side abdominal pain
    Endosonography (diagnostic value in right side abdominal pain)
    Additional relevant MeSH terms:
    Abdominal Pain

    Study Results

    No Results Posted as of Mar 4, 2010