Low vs. Standard Dose CT for Appendicitis Trial
- Conditions
- Appendicitis
- Interventions
- Diagnostic Test: Diagnostic CT with standard-dose radiationDiagnostic Test: Diagnostic CT with low-dose radiation
- Registration Number
- NCT01925014
- Lead Sponsor
- Kyoung Ho Lee, MD
- Brief Summary
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).
- Detailed Description
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3074
- Emergency department visit with suspected symptoms and signs of acute appendicitis
- Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis
- Willing to provide telephone or cell phone numbers for follow-up
- Signed informed consent provided prior to study entry
- Prior cross-sectional imaging tests to evaluate the presenting symptoms and signs
- Prior history of surgical removal of the appendix
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard-dose CT Diagnostic CT with standard-dose radiation Diagnostic CT with standard-dose radiation Low-dose CT Diagnostic CT with low-dose radiation Diagnostic CT with low-dose radiation
- Primary Outcome Measures
Name Time Method Negative Appendectomy Rate 1 week after surgery 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).
- Secondary Outcome Measures
Name Time Method Number of Appendectomies 3 months after CT Appendectomy rate. The percentage of appendectomies among all randomized cases.
Number of Negative Appendectomies 1 week after surgery 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.
Prevalence of Non-perforated Appendicitis 1 week after surgery 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.
Appendiceal Perforation Rate 1 week after surgery The percentage of perforated appendicitis among confirmed appendicitis cases.
Prevalence of Perforated Appendicitis 1 week after surgery 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.
Need for Additional Imaging Test(s) 1 week after CT The proportion of patients requiring additional imaging test(s) in order to diagnose or rule out appendicitis.
Delay in Patient Disposition 3 months after CT * 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.Length of Hospital Stay Associated With Appendectomy 3 months after CT The interval from CT acquisition to hospital discharge after appendectomy.
Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Indeterminate Interpretation (Grade 3) 3 months after CT 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.
Diagnostic Performance of CT Reports - AUC 3 months after CT - Area under the receiver-operating-characteristic curve (AUC).
Diagnostic Performance of CT Reports - Sensitivity and Specificity 3 months after CT * 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.Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Likelihood Score for Appendicitis 3 months after CT * 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.Diagnostic Confidence in Ruling Out Appendicitis: Normal Appendix Visualization 3 months after CT 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.
Diagnosis of Appendiceal Perforation at CT 3 months after 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.
Trial Locations
- Locations (20)
Kangwon National University Hospital
🇰🇷Chuncheon, Gangwon, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Gyeonggi, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Gyeonggi, Korea, Republic of
Wonkwang University Sanbon Hospital
🇰🇷Sanbon, Gyeonggi, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon, Gyeonggi, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Daejin Medical Center, Bundang Jesaeng General Hospital
🇰🇷Seongnam, Gyeonggi, Korea, Republic of
Wonkwang University School of Medicine & Hospital
🇰🇷Iksan, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Jeju National University Hospital
🇰🇷Jeju City, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, College of Medicine, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of