N/A
N=3,074
Low vs. Standard Dose CT for Appendicitis Trial
Appendicitis
Bottom Line
View on ClinicalTrials.gov: NCT01925014 ↗Enrolled (actual)
3,074
Serious AEs
2.7%
Results posted
Jan 2019
Primary outcome: Primary: Negative Appendectomy Rate — 22; 16; 21; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diagnostic CT with low-dose radiation (Diagnostic_test); Diagnostic CT with standard-dose radiation (Diagnostic_test)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Kyoung Ho Lee, MD
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Negative Appendectomy Rate |
22; 16; 21; 16 | — |
| SECONDARY Appendiceal Perforation Rate |
182; 176 | — |
| SECONDARY Number of Appendectomies |
559; 601 | — |
| SECONDARY Number of Negative Appendectomies |
22; 16 | — |
| SECONDARY Prevalence of Perforated Appendicitis |
182; 176 | — |
| SECONDARY Prevalence of Non-perforated Appendicitis |
342; 388 | — |
| SECONDARY Need for Additional Imaging Test(s) |
39; 41 | — |
| SECONDARY Delay in Patient Disposition |
5.3; 5.4; 1.7; 1.6 | — |
| SECONDARY Length of Hospital Stay Associated With Appendectomy |
3.0; 2.9 | — |
| SECONDARY Diagnostic Performance of CT Reports - AUC |
0.983; 0.986 | — |
| SECONDARY Diagnostic Performance of CT Reports - Sensitivity and Specificity |
97.1; 98.0; 95.8; 94.0 | — |
| SECONDARY Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Likelihood Score for Appendicitis |
6; 6; 9; 5; 18; 19 | — |
| SECONDARY Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Indeterminate Interpretation (Grade 3) |
34; 53 | — |
| SECONDARY Diagnostic Confidence in Ruling Out Appendicitis: Normal Appendix Visualization |
36; 14; 137; 64; 762; 787 | — |
| SECONDARY Diagnosis of Appendiceal Perforation at CT |
43; 43; 89; 91 | — |
Summary
To determine whether low-dose (LD) CT is noninferior to standard-dose (SD) computed tomography (CT) as the first-line imaging test in adolescents and young adults in regard to negative appendectomy rate (NAR).
Eligibility Criteria
Inclusion Criteria
- Emergency department visit with suspected symptoms and signs of acute appendicitis
- Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis
- Willing to provide telephone or cell phone numbers for follow-up
- Signed informed consent provided prior to study entry
Exclusion Criteria
- Prior cross-sectional imaging tests to evaluate the presenting symptoms and signs
- Prior history of surgical removal of the appendix
Data sourced from ClinicalTrials.gov (NCT01925014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.