Emergency Department CT Scanning for Appendicitis

Sponsor

WellSpan Health (Other)

Overall Status

Completed

CT.gov ID

NCT00734825

Collaborator

(none)

244

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Nov 1, 2006

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

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

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

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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