Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-29 @ 11:56 AM
Study NCT ID:
NCT00716703
Status:
COMPLETED
Last Update Posted:
2008-07-16
First Post:
2008-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT Scan Using IV Contrast Alone for Pediatric Appendicitis
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
CT Scan Using IV Contrast Alone for Pediatric Appendicitis
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: