Emergency Department CT Scanning for Appendicitis

NCT ID: NCT00734825

Last Updated: 2012-06-28

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

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to compare IV contrast only vs. IV and oral contrast Computed Tomography (CT) for the diagnosis of acute appendicitis in adult patients in our emergency department. A secondary purpose will be to design a specific CT for appendicitis protocol at our institution at the conclusion of this study.

Detailed Description

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Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

IV contrast

Group Type ACTIVE_COMPARATOR

Omnipaque

Intervention Type OTHER

oral contrast for CT scan

2

IV contrast and oral contrast

Group Type ACTIVE_COMPARATOR

Omnipaque

Intervention Type OTHER

oral contrast for CT scan

Interventions

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Omnipaque

oral contrast for CT scan

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years and older who present to the York Hospital Emergency Department with signs and symptoms suggestive of acute appendicitis, but in whom the diagnosis remains unclear as determined by an attending emergency physician or consulting surgeon and in which a CT scan is needed to further assist in the diagnosis

Exclusion Criteria

* pregnant patients
* patients with known IV dye or oral contrast allergy
* patients in whom acute appendicitis is not the primary diagnosis
* patients with renal insufficiency that may have significant adverse effect from IV dye
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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WellSpan Health

OTHER

Sponsor Role lead

Responsible Party

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WellSpan HEalth

Principal Investigators

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Andrew Kepner, MD

Role: PRINCIPAL_INVESTIGATOR

WellSpan Health

References

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Kepner AM, Bacasnot JV, Stahlman BA. Intravenous contrast alone vs intravenous and oral contrast computed tomography for the diagnosis of appendicitis in adult ED patients. Am J Emerg Med. 2012 Nov;30(9):1765-73. doi: 10.1016/j.ajem.2012.02.011. Epub 2012 May 23.

Reference Type DERIVED
PMID: 22633722 (View on PubMed)

Other Identifiers

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0607012

Identifier Type: -

Identifier Source: org_study_id

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