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Emergency Ultrasound of the Gallbladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00388830
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : November 2, 2012
Sponsor:
Information provided by:
Christiana Care Health Services

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

Condition or disease Intervention/treatment Phase
Gallbladder Diseases Procedure: Ultrasound Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: "Emergency Bedside Ultrasonography of the Gallbladder: Does Fasting Matter?"
Study Start Date : May 2006
Actual Study Completion Date : July 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. time to perform scan
  2. diagnosis of pathology
  3. performance of adequate measurement
  4. overall adequacy of the scan

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388830


Locations
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United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
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Study Director: Robert O'Connor, MD, MPH Christiana Care Health Services
More Information
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ClinicalTrials.gov Identifier: NCT00388830    
Other Study ID Numbers: 26046
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: November 2, 2012
Last Verified: November 2012
Keywords provided by Christiana Care Health Services:
Gallbladder
Ultrasound
Emergency Medicine
Additional relevant MeSH terms:
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Gallbladder Diseases
Emergencies
Disease Attributes
 Pathologic Processes
Biliary Tract Diseases
Digestive System Diseases