CT Scan Using IV Contrast Alone for Pediatric Appendicitis
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.
- 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).
- To determine test performance characteristics (specificity, sensitivity and diagnostic accuracy) of CT IV in detecting appendicitis in children.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||CT Scan Using IV Contrast Alone for Pediatric Appendicitis|
- Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast alone [ Time Frame: Study completion date ] [ Designated as safety issue: No ]
- Time to CT scan for CT with IV contrast alone v. CT using both IV and oral contrast [ Time Frame: study completion date ] [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
|Study Completion Date:||October 2005|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
cohort = pediatric patients in the ED (3-18 yo) with abdominal pain suspicious for appendicitis that are to undergo CT scan
Other: CT Scan using IV contrast alone
CT scan using IV contrast alone
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716703
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Madelyn Garcia, MD, MPH||University of Rochester|
|Principal Investigator:||Lynn Babcock-Cimpello, MD||University of Rochester|