Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study) (EFRAIM)
Primary Purpose
Abdominal Pain
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
EGD
EUS
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Pain focused on measuring endosonography, right side abdominal pain, Endosonography (diagnostic value in right side abdominal pain)
Eligibility Criteria
Inclusion Criteria:
- acute right side abdominal pain
- willing participate study
Exclusion Criteria:
- acute disease
- malignancy
- other disease which might cause discomfort
Sites / Locations
- Klinikum r.d. Isar, Technical University MunichRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
EGD
EUS
Arm Description
In this arm EGD will be performed before EUS
In this arm, EUS will be performed before EGD.
Outcomes
Primary Outcome Measures
Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.
Secondary Outcome Measures
Calculate the time and cost savings and number of procedures for endosonography alone versus the combined approach of abd. sonography, gastroscopy and endosonography.
Full Information
NCT ID
NCT01080690
First Posted
January 27, 2010
Last Updated
March 3, 2010
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT01080690
Brief Title
Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
Acronym
EFRAIM
Official Title
Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Technical University of Munich
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
endosonography, right side abdominal pain, Endosonography (diagnostic value in right side abdominal pain)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EGD
Arm Type
Active Comparator
Arm Description
In this arm EGD will be performed before EUS
Arm Title
EUS
Arm Type
Active Comparator
Arm Description
In this arm, EUS will be performed before EGD.
Intervention Type
Procedure
Intervention Name(s)
EGD
Other Intervention Name(s)
EGD: A standard diagnostic EGD will be performed., EUS: A standard diagnostic EUS will be performed.
Intervention Description
In this arm EGD will be performed before EUS.
Intervention Type
Procedure
Intervention Name(s)
EUS
Intervention Description
In this arm EUS will be performed before EGD.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute right side abdominal pain
willing participate study
Exclusion Criteria:
acute disease
malignancy
other disease which might cause discomfort
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valentin Becker, Dr.
Phone
+49 89 41400
Email
valentin.becker@lrz.tum.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Meining, Prof.
Organizational Affiliation
II Med Dep, TU Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum r.d. Isar, Technical University Munich
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Meining, Prof.
Phone
+49 89 41400
Email
valentin.becker@lrz.tum.de
12. IPD Sharing Statement
Learn more about this trial
Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
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