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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Technische Universität München.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01080690
First received: January 27, 2010
Last updated: March 3, 2010
Last verified: February 2010
  Purpose

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 Intervention
Abdominal Pain
Procedure: EGD
Procedure: EUS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

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. [ Time Frame: within the first week of complaints ] [ Designated as safety issue: Yes ]

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. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: January 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute right side abdominal pain
  • willing participate study

Exclusion Criteria:

  • acute disease
  • malignancy
  • other disease which might cause discomfort
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080690

Contacts
Contact: Valentin Becker, Dr. +49 89 41400 valentin.becker@lrz.tum.de

Locations
Germany
Klinikum r.d. Isar, Technical University Munich Recruiting
Munich, Germany
Contact: Alexander Meining, Prof.    +49 89 41400    valentin.becker@lrz.tum.de   
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Alexander Meining, Prof. II Med Dep, TU Munich
  More Information

No publications provided

Responsible Party: Prof. A. Meining, TUM, Technical University Munich
ClinicalTrials.gov Identifier: NCT01080690     History of Changes
Other Study ID Numbers: 01102
Study First Received: January 27, 2010
Last Updated: March 3, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
endosonography, right side abdominal pain
Endosonography (diagnostic value in right side abdominal pain)

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on September 16, 2014