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Emergency Ultrasound of the Gallbladder

NCT ID: NCT00388830

Last Updated: 2012-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Gallbladder Diseases

Keywords

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Gallbladder Ultrasound Emergency Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Interventions

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Ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Principal Investigators

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Robert O'Connor, MD, MPH

Role: STUDY_DIRECTOR

Christiana Care Health Services

Locations

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Christiana Care Health Services

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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26046

Identifier Type: -

Identifier Source: org_study_id