Emergency Ultrasound of the Gallbladder

Gallbladder Diseases Clinical Trial

Official title:

"Emergency Bedside Ultrasonography of the Gallbladder: Does Fasting Matter?"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388830
• Other study ID #: 26046
• 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
• 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

• Emergencies
• Gallbladder Diseases

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