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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00388830
Other study ID # 26046
Secondary ID
Status Completed
Phase N/A
First received October 13, 2006
Last updated November 1, 2012
Start date May 2006
Est. completion date July 2007

Study information

Verified date November 2012
Source Christiana Care Health Services
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound


Locations

Country Name City State
United States Christiana Care Health Services Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary time to perform scan
Primary diagnosis of pathology
Primary performance of adequate measurement
Primary overall adequacy of the scan
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