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| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
| Seoul National University Bundang Hospital | OTHER |
| Radiology Imaging Network of Korea for Clinical Research | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose CT | Experimental | Diagnostic CT with low-dose radiation |
|
| Standard-dose CT | Active Comparator | Diagnostic CT with standard-dose radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic CT with low-dose radiation | Diagnostic Test | Effective dose is aimed at approximately 2 millisievert (mSv) in an average patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Appendiceal Perforation Rate | The percentage of perforated appendicitis among confirmed appendicitis cases. | 1 week after surgery |
| Number of Appendectomies | Appendectomy rate. The percentage of appendectomies among all randomized cases. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyoung Ho Lee, MD | Seoul National University Bundang Hospital | Study Chair |
| Kyuseok Kim, MD | Seoul National University Bundang Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangwon National University Hospital | Chuncheon | Gangwon-do | 200-722 | South Korea | ||
| Korea University Ansan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22533576 | Background | 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. | |
| 24438500 | Background | Ahn S; LOCAT group. LOCAT (low-dose computed tomography for appendicitis trial) comparing clinical outcomes following low- vs standard-dose computed tomography as the first-line imaging test in adolescents and young adults with suspected acute appendicitis: study protocol for a randomized controlled trial. Trials. 2014 Jan 17;15:28. doi: 10.1186/1745-6215-15-28. |
| Label | URL |
|---|---|
| LOCAT-Training, a self-learning course to train the radiologists at all Sites to ensure the safety of the participants. | View source |
Not provided
The LOCAT Group has an active standpoint for sharing the LOCAT data, which is in line with the proposal from the International Committee of Medical Journal Editors. The LOCAT Group will share de-identified individual-participant data underlying the main LOCAT results no later than 6 months after the publication of the results. The data will be kept in a publicly available website and freely available to anyone upon request.
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From 20 Korean teaching hospitals with predominantly limited experience in low-dose CT
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Low-dose CT | 2 millisievert |
| FG001 | Standard-dose CT | 8 millisievert or lower |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| The LOCAT Group |
| UNKNOWN |
Not provided
Not provided
Not provided
Not provided
| Diagnostic CT with standard-dose radiation | Diagnostic Test | Effective dose is aimed at approximately 8 millisievert (or less) in an average patient. |
|
|
| 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. | 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. | 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. | 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. | 1 week after CT |
| Delay in Patient Disposition |
| 3 months after CT |
| Length of Hospital Stay Associated With Appendectomy | The interval from CT acquisition to hospital discharge after appendectomy. | 3 months after CT |
| Diagnostic Performance of CT Reports - AUC | - Area under the receiver-operating-characteristic curve (AUC). | 3 months after CT |
| Diagnostic Performance of CT Reports - Sensitivity and Specificity |
| 3 months after CT |
| Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Likelihood Score for 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. | 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. | 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. | 3 months after CT |
| Diagnosis of Appendiceal Perforation at CT |
| 3 months after CT |
| Ansan |
| Gyeonggi-do |
| 425-707 |
| South Korea |
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | 431-070 | South Korea |
| Soonchunhyang University Bucheon Hospital | Bucheon-si | Gyeonggi-do | 420-767 | South Korea |
| Wonkwang University Sanbon Hospital | Sanbon | Gyeonggi-do | 435-040 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| Daejin Medical Center, Bundang Jesaeng General Hospital | Seongnam-si | Gyeonggi-do | 463-774 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 700-712 | South Korea |
| Chonnam National University Hospital | Gwangju | 501-757 | South Korea |
| Wonkwang University School of Medicine & Hospital | Iksan | 570-711 | South Korea |
| Gachon University Gil Medical Center | Incheon | 405-760 | South Korea |
| Jeju National University Hospital | Jeju City | 690-767 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 110-746 | South Korea |
| Severance Hospital | Seoul | 120-752 | South Korea |
| The Catholic University of Korea, College of Medicine, Seoul St. Mary's Hospital | Seoul | 137-701 | South Korea |
| Soonchunhyang University Seoul Hospital | Seoul | 140-887 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | 150-950 | South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| Chung-Ang University Hospital | Seoul | 156-755 | South Korea |
| Background | Ko Y, Choi JW, Kim DH, Lee KJ, Shin SS, Woo JY, Cho SW, Kim BS, Lee KH. Central image archiving and management system for multicenter clinical studies: lessons from low-dose CT for appendicitis trial. J Korean Soc Radiol. 2017 Mar 28;76(3):165-72. doi: 10.3348/jksr.2017.76.3.165. |
| 26587949 | Background | Yang HK, Ko Y, Lee MH, Woo H, Ahn S, Kim B, Pickhardt PJ, Kim MS, Park SB, Lee KH; Low-Dose CT for Appendicitis Trial (LOCAT) Group. Initial Performance of Radiologists and Radiology Residents in Interpreting Low-Dose (2-mSv) Appendiceal CT. AJR Am J Roentgenol. 2015 Dec;205(6):W594-611. doi: 10.2214/AJR.15.14513. |
| 33825498 | Derived | Kim HY, Lee S, Kim DH, Ko Y, Park JH, Ko A, Jeong SM, Park SB, Lee KH; LOCAT Group. Conventional-Dose CT Versus 2-mSv CT for Right Colonic Diverticulitis as an Alternate Diagnosis of Appendicitis: Secondary Analysis of Large Pragmatic Randomized Trial Data. AJR Am J Roentgenol. 2021 Nov;217(5):1113-1121. doi: 10.2214/AJR.21.25584. Epub 2021 Apr 7. |
| 28919126 | Derived | LOCAT Group. Low-dose CT for the diagnosis of appendicitis in adolescents and young adults (LOCAT): a pragmatic, multicentre, randomised controlled non-inferiority trial. Lancet Gastroenterol Hepatol. 2017 Nov;2(11):793-804. doi: 10.1016/S2468-1253(17)30247-9. Epub 2017 Sep 12. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low-dose CT | 2 millisievert |
| BG001 | Standard-dose CT | 8 millisievert or lower |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Missing data due to withdrawal and inappropriate enrollment. | Median | Inter-Quartile Range | years |
| ||||||||||||||
| Sex: Female, Male | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Body mass index (kg/m²) | Missing data due to withdrawal and inappropriate enrollment. | Median | Inter-Quartile Range | kg/m² |
| ||||||||||||||
| Body mass index (kg/m²) | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Effective diameter (cm) | The square root of the product of the anteroposterior diameter and lateral diameter of the abdomen, as measured on the transverse CT image at the umbilicus level. | Missing data due to withdrawal and inappropriate enrollment. | Median | Inter-Quartile Range | cm |
| |||||||||||||
| Effective diameter (cm) | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Chief complaint | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Duration of symptoms | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Location of abdominal pain | Patients may fall into more than one category. Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Migration of pain | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Abdominal tenderness | Patients may fall into more than one category. Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Rebound tenderness | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Body temperature | Missing data due to withdrawal and inappropriate enrollment. | Median | Inter-Quartile Range | ℃ |
| ||||||||||||||
| White blood cell (10³/mm³) | Missing data due to withdrawal and inappropriate enrollment. | Median | Inter-Quartile Range | 10³ cells/mm³ |
| ||||||||||||||
| Segmented neutrophil (%) | Missing data due to withdrawal and inappropriate enrollment. | Median | Inter-Quartile Range | percentage of neutrophils |
| ||||||||||||||
| C-reactive protein (mg/dL) | Missing data due to withdrawal and inappropriate enrollment. | Median | Inter-Quartile Range | mg/dL |
| ||||||||||||||
| Alvarado score | Alvarado score is a clinical scoring system used in the diagnosis of appendicitis. The score has 6 clinical items and 2 laboratory measurements with a total 10 points. A greater Alvarado score indicates a higher likelihood of appendicitis. | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| ||||||||||||||
| Appendicitis inflammatory response score | The appendicitis inflammatory response (AIR) score is a clinical scoring system used in the diagnosis of appendicitis. The score has 4 clinical items and 3 laboratory measurements with a total 12 points. A greater AIR score indicates a higher likelihood of appendicitis. | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| ||||||||||||||
| Time of CT examination | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| CT machine | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Target effective dose (low-dose CT vs. standard-dose CT) | While the effective dose for low-dose CT was aimed at 2 mSv for all CT machines, the target effective dose for standard-dose CT was individualized for each CT machine following the institutional normal dose. | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| ||||||||||||||
| Dose-length product (mGy·cm) | Missing data due to withdrawal and inappropriate enrollment. | Median | Inter-Quartile Range | mGy·cm |
| ||||||||||||||
| Volume CT dose index (mGy) | Missing data due to withdrawal and inappropriate enrollment. | Median | Inter-Quartile Range | mGy |
| ||||||||||||||
| Size-specific dose estimate (mGy) | Missing data due to withdrawal and inappropriate enrollment. | Median | Inter-Quartile Range | mGy |
| ||||||||||||||
| Iterative reconstruction | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Radiologist who made initial CT report | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Site characteristics: low-dose CT experience in the previous trial | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Site characteristics: number of beds | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Site characteristics: annual number of appendectomies | Missing data due to withdrawal and inappropriate enrollment. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Patients who underwent appendectomy. Intention-to-treat. | Posted | Count of Participants | Participants | 1 week after surgery |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Appendiceal Perforation Rate | The percentage of perforated appendicitis among confirmed appendicitis cases. | Patients confirmed as having appendicitis. Intention-to-treat. | Posted | Count of Participants | Participants | 1 week after surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Appendectomies | Appendectomy rate. The percentage of appendectomies among all randomized cases. | Intention-to-treat. | Posted | Count of Participants | Participants | 3 months after CT |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention-to-treat. | Posted | Count of Participants | Participants | 1 week after surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention-to-treat. | Posted | Count of Participants | Participants | 1 week after surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention-to-treat. | Posted | Count of Participants | Participants | 1 week after surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Need for Additional Imaging Test(s) | The proportion of patients requiring additional imaging test(s) in order to diagnose or rule out appendicitis. | Intention-to-treat. | Posted | Count of Participants | Participants | 1 week after CT |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Delay in Patient Disposition |
| Intention-to-treat. | Posted | Median | Inter-Quartile Range | Hours | 3 months after CT |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Hospital Stay Associated With Appendectomy | The interval from CT acquisition to hospital discharge after appendectomy. | Patients who underwent appendectomy. Intention-to-treat. Interval appendectomies following percutaneous abscess drainage and/or medical treatment were not included in this analysis. | Posted | Median | Inter-Quartile Range | Days | 3 months after CT |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Diagnostic Performance of CT Reports - AUC | - Area under the receiver-operating-characteristic curve (AUC). | Patients with incomplete reference standards were not included in these analyses. Intention-to-treat. | Posted | Number | AUC | 3 months after CT |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Diagnostic Performance of CT Reports - Sensitivity and Specificity |
| Patients with incomplete reference standards were not included in these analyses. Intention-to-treat. | Posted | Number | percentage | 3 months after CT |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Likelihood Score for 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. | Patients with incomplete reference standards were not included in these analyses. Intention-to-treat. | Posted | Count of Participants | Participants | 3 months after CT |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Patients with incomplete reference standards were not included in these analyses. Intention-to-treat. | Posted | Count of Participants | Participants | 3 months after CT |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Patients confirmed as not having appendicitis. Intention-to-treat. | Posted | Count of Participants | Participants | 3 months after CT |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Diagnosis of Appendiceal Perforation at CT |
| Patients confirmed to have appendicitis. Intention-to-treat. | Posted | Number | Percentage | 3 months after CT |
|
|
3 months
Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-dose CT | 2 millisievert | 0 | 1,535 | 43 | 1,535 | 0 | 1,535 |
| EG001 | Standard-dose CT | 8 millisievert or lower | 0 | 1,539 | 40 | 1,539 | 0 | 1,539 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Gastrointestinal disorders-other, specify | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Anaphylaxis | Immune system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Joint infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Pelvic infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
| |
| Large intestinal anastomotic leak | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Ischemia cerebrovascular | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Psychosis | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Surgical and medical procedures- other, specify | Surgical and medical procedures | CTCAE 4.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kyoung Ho Lee | The LOCAT Group | 82317877607 | kholeemail@gmail.com |
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
Not provided
Not provided
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| Suprapubic |
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| Right flank |
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| Periumbilical |
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| Epigastric |
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| Other area(s) |
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| No pain |
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| Epigastric |
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| Left lower quadrant |
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| Suprapubic |
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| Periumbilical |
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| Other area(s) |
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| No tenderness |
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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| Grade 5 |
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