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Emergency Department CT Scanning for Appendicitis

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ClinicalTrials.gov Identifier: NCT00734825
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : June 28, 2012
Sponsor:
Information provided by:
WellSpan Health

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Appendicitis Other: Omnipaque Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
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
Study Start Date : November 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : September 2010

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria
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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
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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 Posted: August 14, 2008    Key Record Dates
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