Emergency Department CT Scanning for Appendicitis
June 27, 2012 updated by: WellSpan Health
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
Study Type
Interventional
Enrollment (Actual)
244
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
IV contrast
|
oral contrast for CT scan
|
|
Active Comparator: 2
IV contrast and oral contrast
|
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.
Time Frame: immediate reading + blinded reading within 48 hours
|
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
Time Frame: immediate reading and blinded reading within 48 hours
|
immediate reading and blinded reading within 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Kepner, MD, WellSpan Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0607012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.