Emergency Ultrasound of the Gallbladder
Primary Purpose
Gallbladder Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Gallbladder Diseases focused on measuring Gallbladder, Ultrasound, Emergency Medicine
Eligibility 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
Sites / Locations
- Christiana Care Health Services
Outcomes
Primary Outcome Measures
time to perform scan
diagnosis of pathology
performance of adequate measurement
overall adequacy of the scan
Secondary Outcome Measures
Full Information
NCT ID
NCT00388830
First Posted
October 13, 2006
Last Updated
November 1, 2012
Sponsor
Christiana Care Health Services
1. Study Identification
Unique Protocol Identification Number
NCT00388830
Brief Title
Emergency Ultrasound of the Gallbladder
Official Title
"Emergency Bedside Ultrasonography of the Gallbladder: Does Fasting Matter?"
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Christiana Care Health Services
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether fasting for 8 hours prior to ultrasonography for cholelithiasis (gallbladder pain) is needed.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Diseases
Keywords
Gallbladder, Ultrasound, Emergency Medicine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Primary Outcome Measure Information:
Title
time to perform scan
Title
diagnosis of pathology
Title
performance of adequate measurement
Title
overall adequacy of the scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert O'Connor, MD, MPH
Organizational Affiliation
Christiana Care Health Services
Official's Role
Study Director
Facility Information:
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Emergency Ultrasound of the Gallbladder
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