Clinical trial NCT00716703: CT Scan Using IV Contrast Alone for Pediatric Appendicitis
Official title: CT Scan Using IV Contrast Alone for Pediatric Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Child
Contrast Media
Keywords: Appendicitis
Computed tomography
pediatric
child
sensitivity
specificity
contrast administration route
time factors
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast alone
timeFrame: Study completion date
Secondary outcomes:
measure: Time to CT scan for CT with IV contrast alone v. CT using both IV and oral contrast
timeFrame: study completion date
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Madelyn Garcia, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Lynn Babcock-Cimpello, MD
role: PRINCIPAL_INVESTIGATOR
References: