CT Scan Using IV Contrast Alone for Pediatric Appendicitis

Appendicitis Clinical Trial

Official title:

CT Scan Using IV Contrast Alone for Pediatric Appendicitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716703
• Other study ID #: RSRB9986
• Status: Completed
• Phase: N/A
• First received: July 14, 2008
• Last updated: July 15, 2008
• Start date: November 2003
• Est. completion date: October 2005

Study information

• Verified date: July 2008
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Appendicitis
• Child
• Contrast Media

Intervention

Other:
• CT Scan using IV contrast alone
CT scan using IV contrast alone

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast alone		Study completion date	No
Secondary	Time to CT scan for CT with IV contrast alone v. CT using both IV and oral contrast		study completion date	No