Clinical trial NCT00913380: Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT
Official title: Negative Appendectomy Rate Following Low-dose CT vs. Standard-dose CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Appendicitis
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: GE Healthcare
name: National Research Foundation of Korea
First posted: 2009-06-04
Enrollment: 891
Sex: ALL
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Acute appendicitis is a very common disease with the lifetime incidence of 7%. Abdomen CT is an established first-line diagnostic test in patients suspected of having acute appendicitis. Since many individuals suspected of having acute appendicitis are young, with a mean age of 30 years, CT radiation is of particular concern.

The estimated lifetime attributable risk of death from cancer due to the radiation exposure of a single abdomen CT study is 2-7/10,000 for average adults ranging 20-40 years in age.

The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the negative appendectomy rate.

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

Primary outcomes:
measure: Negative Appendectomy
timeFrame: 1 week after surgery
Secondary outcomes:
measure: Additional Imaging Test(s)
timeFrame: 1 week after CT
measure: Appendiceal Perforation
timeFrame: 1 week after surgery
measure: Interval Between CT and Appendectomy
timeFrame: 1 day after surgery
measure: Interval Between CT and Discharge Without Surgery
timeFrame: 3 months after CT
measure: Interval From CT to Discharge After Appendectomy
timeFrame: 3 months after CT
measure: Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis
timeFrame: 3 months after CT
measure: Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis
timeFrame: 3 months after CT
measure: Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis.
timeFrame: 3 months after CT
measure: Visualization of the Normal Appendix
timeFrame: 3 months after CT
Other outcomes:
measure: Radiation Dose
timeFrame: 1 day after CT
measure: Estimate of Carcinogenic Risk Induced by CT Radiation
timeFrame: 1 day after CT
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Kyoung Ho Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Kyuseok Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim K, Kim YH, Kim SY, Kim S, Lee YJ, Kim KP, Lee HS, Ahn S, Kim T, Hwang SS, Song KJ, Kang SB, Kim DW, Park SH, Lee KH. Low-dose abdominal CT for evaluating suspected appendicitis. N Engl J Med. 2012 Apr 26;366(17):1596-605. doi: 10.1056/NEJMoa1110734.