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).
* Acute appendicitis is a very common disease. Many patients are adolescents or young adults. * CT is the current standard imaging test for the diagnosis of appendicitis. * In recent years, the awareness of carcinogenic risk associated with CT radiation has increased. * According to a recent single-institutional randomized controlled trial, LD CT (employing a quarter of standard radiation dose) was found to be noninferior to SD CT with respect to NARs in adolescents and young adults with suspected appendicitis. * However, LD CT is not yet widely accepted. * To establish LD CT as the first-line imaging test, a multi-institutional study is needed to confirm the generalizability of the prior single-institutional study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
3,074
Effective dose is aimed at approximately 2 millisievert (mSv) in an average patient.
Effective dose is aimed at approximately 8 millisievert (or less) in an average patient.
Kangwon National University Hospital
Chuncheon, Gangwon-do, South Korea
Negative Appendectomy Rate
Negative appendectomy rate was defined as the percentage of negative (unnecessary) appendectomies among all non-incidental appendectomies. As a secondary analysis, negative appendectomy rate in an alternative definition was calculated by excluding cases with appendiceal neoplasms without superimposed appendicitis, as appendectomy would be clinically necessary in such patients. Any surgery performed for the treatment of presumed appendicitis was counted as non-incidental appendectomy, even though the surgical procedures were more extensive than simple appendectomy (e.g., ileocectomy).
Time frame: 1 week after surgery
Appendiceal Perforation Rate
The percentage of perforated appendicitis among confirmed appendicitis cases.
Time frame: 1 week after surgery
Number of Appendectomies
Appendectomy rate. The percentage of appendectomies among all randomized cases.
Time frame: 3 months after CT
Number of Negative Appendectomies
The percentage of negative appendectomies among all randomized cases. In January, 2016, when more than 2000 patients were enrolled, the data and safety monitoring board noted a between-group imbalance in the number of appendectomies. Because of the concern that such an imbalance might potentially jeopardize the comparability for the prespecified endpoints, the study protocol was amended to adopt the following additional secondary endpoints, which were assessed among all randomly assigned patients: the number of appendectomies, number of negative appendectomies, prevalence of perforated appendicitis, and prevalence of non-perforated appendicitis.
Time frame: 1 week after surgery
Prevalence of Perforated Appendicitis
The percentage (i.e., prevalence) of perforated appendicitis among all randomized cases. In January, 2016, when more than 2000 patients were enrolled, the data and safety monitoring board noted a between-group imbalance in the number of appendectomies. Because of the concern that such an imbalance might potentially jeopardize the comparability for the prespecified endpoints, the study protocol was amended to adopt the following additional secondary endpoints, which were assessed among all randomly assigned patients: the number of appendectomies, number of negative appendectomies, prevalence of perforated appendicitis, and prevalence of non-perforated appendicitis.
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Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Wonkwang University Sanbon Hospital
Sanbon, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Daejin Medical Center, Bundang Jesaeng General Hospital
Seongnam-si, Gyeonggi-do, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Wonkwang University School of Medicine & Hospital
Iksan, South Korea
...and 10 more locations
Time frame: 1 week after surgery
Prevalence of Non-perforated Appendicitis
The percentage (i.e., prevalence) of non-perforated appendicitis among all randomized cases. In January, 2016, when more than 2000 patients were enrolled, the data and safety monitoring board noted a between-group imbalance in the number of appendectomies. Because of the concern that such an imbalance might potentially jeopardize the comparability for the prespecified endpoints, the study protocol was amended to adopt the following additional secondary endpoints, which were assessed among all randomly assigned patients: the number of appendectomies, number of negative appendectomies, prevalence of perforated appendicitis, and prevalence of non-perforated appendicitis.
Time frame: 1 week after surgery
Need for Additional Imaging Test(s)
The proportion of patients requiring additional imaging test(s) in order to diagnose or rule out appendicitis.
Time frame: 1 week after CT
Delay in Patient Disposition
* The interval from CT acquisition to appendectomy in patients undergoing appendectomy. Interval appendectomies following percutaneous abscess drainage and/or medical treatment were not included in this analysis. * The interval from CT acquisition to hospital discharge in patients not undergoing surgery.
Time frame: 3 months after CT
Length of Hospital Stay Associated With Appendectomy
The interval from CT acquisition to hospital discharge after appendectomy.
Time frame: 3 months after CT
Diagnostic Performance of CT Reports - AUC
\- Area under the receiver-operating-characteristic curve (AUC).
Time frame: 3 months after CT
Diagnostic Performance of CT Reports - Sensitivity and Specificity
* Diagnostic sensitivity and specificity: the 5-grade likelihood scores for appendicitis were collapsed into binary responses with a decision threshold of a score ≥ 3 as positive for the diagnosis. * Sensitivity is a proportion of the positive test among the patient confirmed as having appendicitis. * Specificity is a proportion of the negative test among the patient confirmed as not having appendicitis.
Time frame: 3 months after CT
Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Likelihood Score for Appendicitis
* Likelihood score for appendicitis in patients confirmed as having appendicitis. * Likelihood score for appendicitis in patients confirmed as not having appendicitis. Grade 1 denotes appendicitis definitely absent; grade 2, appendicitis probably absent; grade 3, indeterminate for the presence of appendicitis; grade 4, appendicitis probably present; and grade 5, appendicitis definitely present.
Time frame: 3 months after CT
Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Indeterminate Interpretation (Grade 3)
The frequency of indeterminate CT interpretation (grade 3). Grade 1 denotes appendicitis definitely absent; grade 2, appendicitis probably absent; grade 3, indeterminate for the presence of appendicitis; grade 4, appendicitis probably present; and grade 5, appendicitis definitely present.
Time frame: 3 months after CT
Diagnostic Confidence in Ruling Out Appendicitis: Normal Appendix Visualization
The frequency of normal appendix visualization at CT. Grade 0 denotes appendix not identified; grade 1, unsure or partly visualized; and grade 2, clearly and entirely visualized.
Time frame: 3 months after CT
Diagnosis of Appendiceal Perforation at CT
* Diagnostic sensitivity: the number of correct detections of the perforation divided by the number of cases of perforated appendicitis. * Diagnostic specificity: the number of correct ruling out the perforation divided by the number of cases of appendicitis without perforation.
Time frame: 3 months after CT