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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
History of Changes
  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:

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
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):

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
Acute Disease
Emergencies
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013