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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
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 27, 2010
Last Updated
March 3, 2010
Sponsor
Technical University of Munich
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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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