CT Scan Using IV Contrast Alone for Pediatric Appendicitis

NCT ID: NCT00716703

Last Updated: 2008-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2005-10-31

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).

Conditions

Appendicitis; Child; Contrast Media

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

CT Scan using IV contrast alone

Intervention Type: OTHER

CT scan using IV contrast alone

Interventions

CT Scan using IV contrast alone

CT scan using IV contrast alone

Intervention Type: OTHER

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)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

University of Rochester, Dept of Emergency Medicine

Principal Investigators

Madelyn Garcia, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Lynn Babcock-Cimpello, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

RSRB9986

Identifier Type: -

Identifier Source: org_study_id