Appendicitis Clinical Trial
Official title:
CT Scan Using IV Contrast Alone for Pediatric Appendicitis
Computed tomography (CT) scan using intravenous contrast (CT IV) as the sole type of
contrast material, was studied as one method of evaluating children with suspected
appendicitis. We felt that this technique could provide physicians with a faster and
better-tolerated alternative to CT imaging which involves patients drinking oral contrast or
needing rectal contrast administered.
SPECIFIC AIMS
1. To test an imaging protocol using CT IV for the evaluation of suspected appendicitis in
children in the setting of a pediatric emergency department (ED).
2. To determine test performance characteristics (specificity, sensitivity and diagnostic
accuracy) of CT IV in detecting appendicitis in children.
This was to be a prospective cohort study imaging pediatric patients (3-18 years old) in
whom the diagnosis of appendicitis was suspected, but not clinically apparent. Patients that
were to have a CT performed would be invited to participate and if enrolled, would be imaged
using CT scan with IV contrast alone.
CT scans would be interpreted in real time by a resident radiologist and/or an attending
radiologist. ED evaluation would remain unchanged and patient disposition would be based on
the discretion of the ED provider using all information (patient exam, labs, surgical
consultation as needed and the results of the CT scan).
CT scan performance would be determined by comparison of the CT interpretation with patient
final outcomes as determined by either (1) pathology reports - in patients that went on to
have surgery (appendectomy) or (2) clinical phone follow up at 24 hrs and then 1 week after
ED discharge.
Performance of CT would be compared between the resident and the attending radiologists.
Further, we would compare the time to obtain a CT scan (defined as ED triage time - Time to
CT) between our study cohort and a retrospective cohort of patients who had received CT scan
in the ED for evaluation of appendicitis pre-study (CT using BOTH IV and oral contrast).
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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