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.

Study Overview

• Status: Completed
• Conditions: Appendicitis
• Intervention / Treatment: Other: Omnipaque

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient.	immediate reading + blinded reading within 48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
If IV contrast alone for CT scan is sensitive for the diagnosis of appendicitis in the adult Emergency department patient	immediate reading and blinded reading within 48 hours

Collaborators and Investigators

• Sponsor: WellSpan Health
• Investigators: Principal Investigator: Andrew Kepner, MD, WellSpan Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: August 12, 2008
• First Submitted That Met QC Criteria: August 13, 2008
• First Posted (Estimate): August 14, 2008

Study Record Updates

• Last Update Posted (Estimate): June 28, 2012
• Last Update Submitted That Met QC Criteria: June 27, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Appendicitis; CT scan; IV Contrast; Oral Contrast
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Emergencies; Appendicitis
• Other Study ID Numbers: 0607012