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CT Scan Using IV Contrast Alone for Pediatric Appendicitis

CT Scan Using IV Contrast Alone for Pediatric Appendicitis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00716703
Enrollment
250
Registered
2008-07-16
Start date
2003-11-30
Completion date
2005-10-31
Last updated
2008-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis, Child, Contrast Media

Keywords

Appendicitis, Computed tomography, pediatric, child, sensitivity, specificity, contrast administration route, time factors

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).

Interventions

OTHERCT Scan using IV contrast alone

CT scan using IV contrast alone

Sponsors

University of Rochester
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast aloneStudy completion date

Secondary

MeasureTime frame
Time to CT scan for CT with IV contrast alone v. CT using both IV and oral contraststudy completion date

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026