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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
891
2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose))
8 mSv in an average patient (Standard-dose CT)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Negative Appendectomy
Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)
Time frame: 1 week after surgery
Additional Imaging Test(s)
Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis
Time frame: 1 week after CT
Appendiceal Perforation
Number of participants with appendiceal perforation
Time frame: 1 week after surgery
Interval Between CT and Appendectomy
Time interval between the CT acquisition and non-incidental appendectomy
Time frame: 1 day after surgery
Interval Between CT and Discharge Without Surgery
Time interval between the CT acquisition and discharge without surgery
Time frame: 3 months after CT
Interval From CT to Discharge After Appendectomy
Time interval between the CT acquisition and discharge after appendectomy
Time frame: 3 months after CT
Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis
Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended. Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data is used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3 months after CT
Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis
Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended. Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data are used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence.
Time frame: 3 months after CT
Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis.
True positive: Perforation was rated as present in CT report and confirmed as present. False positive: Perforation was rated as present in CT report and confirmed as absent. True negative: Perforation was rated as absent in CT report and confirmed as absent. False negative: Perforation was rated as absent in CT report and confirmed as present. The data are used to calculate sensitivity and specificity.
Time frame: 3 months after CT
Visualization of the Normal Appendix
Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized
Time frame: 3 months after CT