Emergency Department CT Scanning for Appendicitis

This study has been completed.
Sponsor:
Information provided by:
WellSpan Health
ClinicalTrials.gov Identifier:
NCT00734825
First received: August 12, 2008
Last updated: June 27, 2012
Last verified: June 2012

August 12, 2008
June 27, 2012
November 2006
November 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00734825 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Emergency Department CT Scanning for Appendicitis
Emergency Department CT Scanning for Appendicitis: IV Contrast vs. IV and Oral Contrast

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Appendicitis
Other: Omnipaque
oral contrast for CT scan
Other Name: Omnipaque
  • Active Comparator: 1
    IV contrast
    Intervention: Other: Omnipaque
  • Active Comparator: 2
    IV contrast and oral contrast
    Intervention: Other: Omnipaque
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
244
September 2010
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00734825
0607012
No
Andrew Kepner, MD / Medical Director, WellSpan Health Simulation Center, WellSpan HEalth
WellSpan Health
Not Provided
Principal Investigator: Andrew Kepner, MD WellSpan Health
WellSpan Health
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP