Emergency Department CT Scanning for Appendicitis

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00734825

First Posted: August 14, 2008

Last Update Posted: June 28, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

WellSpan Health

Purpose

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.

Condition	Intervention
Appendicitis	Other: Omnipaque


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Emergency Department CT Scanning for Appendicitis: IV Contrast vs. IV and Oral Contrast

Resource links provided by NLM:

MedlinePlus related topics: Appendicitis CT Scans Nuclear Scans

U.S. FDA Resources

Further study details as provided by WellSpan Health:

Primary Outcome Measures:

sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient. [ Time Frame: immediate reading + blinded reading within 48 hours ]

Secondary Outcome Measures:

If IV contrast alone for CT scan is sensitive for the diagnosis of appendicitis in the adult Emergency department patient [ Time Frame: immediate reading and blinded reading within 48 hours ]


Enrollment:	244
Study Start Date:	November 2006
Study Completion Date:	September 2010
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 IV contrast	Other: Omnipaque oral contrast for CT scan
Active Comparator: 2 IV contrast and oral contrast	Other: Omnipaque oral contrast for CT scan

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734825

Sponsors and Collaborators

WellSpan Health

Investigators


Principal Investigator:	Andrew Kepner, MD	WellSpan Health

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Andrew Kepner, MD / Medical Director, WellSpan Health Simulation Center, WellSpan HEalth
ClinicalTrials.gov Identifier:	NCT00734825 History of Changes
Other Study ID Numbers:	0607012
First Submitted:	August 12, 2008
First Posted:	August 14, 2008
Last Update Posted:	June 28, 2012
Last Verified:	June 2012

Keywords provided by WellSpan Health:


Appendicitis IV Contrast Oral Contrast CT scan

Additional relevant MeSH terms:


Emergencies Appendicitis Disease Attributes Pathologic Processes Intraabdominal Infections Infection	Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Cecal Diseases Intestinal Diseases

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