Emergency Department CT Scanning for Appendicitis - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Drug Information available for: Iohexol

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]


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 Other Name: Omnipaque
Active Comparator: 2 IV contrast and oral contrast	Other: Omnipaque oral contrast for CT scan Other Name: Omnipaque

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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: NCT00734825

Sponsors and Collaborators

WellSpan Health

Investigators


Principal Investigator:	Andrew Kepner, MD	WellSpan Health

More Information

No publications provided by WellSpan Health

Additional 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
Study First Received:	August 12, 2008
Last Updated:	June 27, 2012
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by WellSpan Health:


Appendicitis IV Contrast Oral Contrast CT scan

Additional relevant MeSH terms:


Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis	Gastrointestinal Diseases Infection Intestinal Diseases Intraabdominal Infections

ClinicalTrials.gov processed this record on March 03, 2015