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

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ClinicalTrials.gov Identifier: NCT01080690
Recruitment Status : Unknown
Verified February 2010 by Technische Universität München.
Recruitment status was:  Recruiting
First Posted : March 4, 2010
Last Update Posted : March 4, 2010
Sponsor:
Information provided by:
Technische Universität München

Tracking Information
First Submitted Date  ICMJE January 27, 2010
First Posted Date  ICMJE March 4, 2010
Last Update Posted Date March 4, 2010
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
Official Title  ICMJE Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Abdominal Pain
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 3, 2010)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • acute right side abdominal pain
  • willing participate study

Exclusion Criteria:

  • acute disease
  • malignancy
  • other disease which might cause discomfort
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01080690
Other Study ID Numbers  ICMJE 01102
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. A. Meining, TUM, Technical University Munich
Study Sponsor  ICMJE Technische Universität München
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexander Meining, Prof. II Med Dep, TU Munich
PRS Account Technische Universität München
Verification Date February 2010

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