Phase 3
N=891
Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT
Appendicitis
Bottom Line
View on ClinicalTrials.gov: NCT00913380 ↗Enrolled (actual)
891
Serious AEs
2.7%
Results posted
Sep 2011
Primary outcome: Primary: Negative Appendectomy — 6; 6; 166; 180 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Diagnostic CT (Radiation)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Seoul National University Bundang Hospital
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Negative Appendectomy |
6; 6; 166; 180 | — |
| SECONDARY Additional Imaging Test(s) |
14; 7; 424; 434 | — |
| SECONDARY Appendiceal Perforation |
44; 42; 122; 138 | — |
| SECONDARY Interval Between CT and Appendectomy |
7.1; 5.6 | — |
| SECONDARY Interval Between CT and Discharge Without Surgery |
2.5; 2.4 | — |
| SECONDARY Interval From CT to Discharge After Appendectomy |
3.4; 3.2 | — |
| SECONDARY Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis |
2; 4; 7; 5; 13; 11 | — |
| SECONDARY Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis |
185; 206; 65; 38; 11; 11 | — |
| SECONDARY Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis. |
16; 23; 11; 17; 110; 121 | — |
| SECONDARY Visualization of the Normal Appendix |
18; 13; 41; 20; 209; 227 | — |
Summary
The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the rate of unnecessary appendectomy.
Eligibility Criteria
Inclusion Criteria
- Suspected of having acute appendicitis
- Referred for abdomen CT from Emergency Department
Exclusion Criteria
- Body mass index < 18.5 kg/m2 (ultrasonography is favored)
- Intravenous contrast-enhancement is contraindicated
Data sourced from ClinicalTrials.gov (NCT00913380). 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.