CT Scan Using IV Contrast Alone for Pediatric Appendicitis

Not Applicable

Completed

• Conditions: Appendicitis; Child; Contrast Media
• Interventions: Other: CT Scan using IV contrast alone

• Registration Number: NCT00716703
• Lead Sponsor: University of Rochester

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).

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2008-07
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-15
• Last Update Submitted: 2008-07-15
• Study First Posted: 2008-07-16
• Last Update Posted: 2008-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CT Scan using IV contrast alone	cohort = pediatric patients in the ED (3-18 yo) with abdominal pain suspicious for appendicitis that are to undergo CT scan

Primary Outcome Measures

Name	Time	Method
Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast alone	Study completion date

Secondary Outcome Measures

Name	Time	Method
Time to CT scan for CT with IV contrast alone v. CT using both IV and oral contrast	study completion date

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States