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Phase 3 Completed N=891 Randomized Single-blind Diagnostic

Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT

Source: ClinicalTrials.gov NCT00913380 ↗
Enrolled (actual)
891
Serious AEs
2.7%
Results posted
Sep 2011
Primary outcomePrimary: Negative Appendectomy — 6; 6; 166; 180 participants

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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