Emergency Ultrasound of the Gallbladder

This study has been completed.
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00388830
First received: October 13, 2006
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Gallbladder Diseases
Procedure: Ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: "Emergency Bedside Ultrasonography of the Gallbladder: Does Fasting Matter?"

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • time to perform scan
  • diagnosis of pathology
  • performance of adequate measurement
  • overall adequacy of the scan

Estimated Enrollment: 70
Study Start Date: May 2006
Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388830

Locations
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Study Director: Robert O'Connor, MD, MPH Christiana Care Health Services
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00388830     History of Changes
Other Study ID Numbers: 26046
Study First Received: October 13, 2006
Last Updated: November 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Gallbladder
Ultrasound
Emergency Medicine

Additional relevant MeSH terms:
Emergencies
Gallbladder Diseases
Disease Attributes
Pathologic Processes
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014