- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00388830
Emergency Ultrasound of the Gallbladder
November 1, 2012 updated by: Christiana Care Health Services
"Emergency Bedside Ultrasonography of the Gallbladder: Does Fasting Matter?"
The purpose of this study is to determine whether fasting for 8 hours prior to ultrasonography for cholelithiasis (gallbladder pain) is needed.
Study Overview
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 Type
Interventional
Enrollment
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Delaware
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Newark, Delaware, United States, 19718
- Christiana Care Health Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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time to perform scan
|
diagnosis of pathology
|
performance of adequate measurement
|
overall adequacy of the scan
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Robert O'Connor, MD, MPH, Christiana Care Health Services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
October 13, 2006
First Submitted That Met QC Criteria
October 13, 2006
First Posted (Estimate)
October 17, 2006
Study Record Updates
Last Update Posted (Estimate)
November 2, 2012
Last Update Submitted That Met QC Criteria
November 1, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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