|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00734825 |
|
Date of registration:
|
12/08/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Emergency Department CT Scanning for Appendicitis
|
|
Scientific title:
|
Emergency Department CT Scanning for Appendicitis: IV Contrast vs. IV and Oral Contrast |
|
Date of first enrolment:
|
November 2006 |
|
Target sample size:
|
244 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00734825 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Andrew Kepner, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
WellSpan Health |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Appendicitis
|
|
Intervention(s)
|
|
Other: Omnipaque
|
|
Primary Outcome(s)
|
|
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]
|
|
Secondary Outcome(s)
|
|
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]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|