CT Scan Using IV Contrast Alone for Pediatric Appendicitis

Study Overview
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Brief Summary
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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 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). To determine test performance characteristics (specificity, sensitivity and diagnostic accuracy) of CT IV in detecting appendicitis in children.

Detailed Description
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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).

Official Title
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CT Scan Using IV Contrast Alone for Pediatric Appendicitis

Conditions
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Appendicitis, Child, Contrast Media

Intervention / Treatment
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* Other: CT Scan using IV contrast alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 3- 18 years Signs/symptoms for < 72 hours CT Scan requested for evaluation by attending or fellow Exclusion Criteria: Clinically apparent appendicitis Pregnancy Sickle Cell Disease Known contrast allergy Previous enrollment Signs/symptoms for > 72 hrs Known abdominal disease (e.g. Crohn's) Exam unreliable (neurologically impaired patient)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>cohort = pediatric patients in the ED (3-18 yo) with abdominal pain suspicious for appendicitis that are to undergo CT scan | Other: CT Scan using IV contrast alone<br>* CT scan using IV contrast alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast alone |  | Study completion date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to CT scan for CT with IV contrast alone v. CT using both IV and oral contrast |  | study completion date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appendicitis, Computed tomography, pediatric, child, sensitivity, specificity, contrast administration route, time factors