CT Scan Using IV Contrast Alone for Pediatric Appendicitis

University of Rochester

Status: Completed

Conditions: Appendicitis; Child; Contrast Media

Treatments: Other: CT Scan using IV contrast alone

Study type: Interventional

Funder types: Other

Identifiers

NCT00716703

RSRB9986

Details and patient eligibility

About

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.

Full 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).

Enrollment: 250 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

1

Experimental group

Description:

cohort = pediatric patients in the ED (3-18 yo) with abdominal pain suspicious for appendicitis that are to undergo CT scan

Treatment:

Other: CT Scan using IV contrast alone