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Emergency Ultrasound of the Gallbladder

This study has been completed.

Sponsored by: Christiana Care Health Services
Information provided by: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00388830
  Purpose

The purpose of this study is to determine whether fasting for 8 hours prior to ultrasonography for cholelithiasis (gallbladder pain) is needed.


Condition Intervention
Gallbladder Diseases
Procedure: Ultrasound

MedlinePlus related topics:   Gallbladder Diseases    Ultrasound   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   "Emergency Bedside Ultrasonography of the Gallbladder: Does Fasting Matter?"

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • time to perform scan
  • diagnosis of pathology
  • performance of adequate measurement
  • overall adequacy of the scan

Estimated Enrollment:   70
Study Start Date:   May 2006
Study Completion Date:   July 2007

Detailed Description:

Ultrasonography of the gallbladder is currently the diagnostic modality of choice in determining cholelithiasis and cholecystitis. Historically this test has been performed in the Radiology suites where the patient was expected to fast for times of six to ten hours. Patients presenting to emergency departments (ED) have also been required to wait to have their study performed in order to have better visualization of the gallbladder. However, few studies have examined whether a fasting time matters in determining gallbladder pathology. Furthermore, with the emphasis on through-times in the ED, most EDs cannot afford holding their patients in the ED to wait for a test. Finally, with the advent of emergency bedside ultrasonography and the greater level of comfort emergency physicians (EP) have in diagnosing gallbladder pathology, it is possible to now determine an answer within minutes. We will test to see if EPs trained in the use of emergency bedside ultrasound can effectively and efficiently determine gallbladder pathology and if fasting has an impact on their ability to perform a quality ultrasound.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Male or female between the ages of 18 and 75
  • Ability to consent for study

Exclusion Criteria:

  • Inability to give informed consent
  • Known pregnancy
  • Prior cholecystectomy
  • Inability to consume a fast food breakfast
  • Known history of cholelithiasis
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388830

Locations
United States, Delaware
Christiana Care Health Services    
      Newark, Delaware, United States, 19718

Sponsors and Collaborators
Christiana Care Health Services

Investigators
Study Director:     Robert O'Connor, MD, MPH     Christiana Care Health Services    
  More Information


Study ID Numbers:   26046
First Received:   October 13, 2006
Last Updated:   October 5, 2007
ClinicalTrials.gov Identifier:   NCT00388830
Health Authority:   United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Gallbladder  
Ultrasound  
Emergency Medicine  

Study placed in the following topic categories:
Gallbladder Diseases
Digestive System Diseases
Biliary Tract Diseases
Emergencies

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 19, 2008




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