Emergency Department CT Scanning for Appendicitis

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

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Principal Investigator: Andrew Kepner, MD WellSpan Health
  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 
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:
IV Contrast
Oral Contrast
CT scan

Additional relevant MeSH terms:
Cecal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Intraabdominal Infections

ClinicalTrials.gov processed this record on May 26, 2016