Trial · NCT01925014
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Appendiceal Perforation Rate | 1 week after surgery | The percentage of perforated appendicitis among confirmed appendicitis cases. |
| Secondary | Number of Appendectomies | 3 months after CT | Appendectomy rate. The percentage of appendectomies among all randomized cases. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Length of Hospital Stay Associated With Appendectomy | 3 months after CT | The interval from CT acquisition to hospital discharge after appendectomy. |
| Secondary | Diagnostic Performance of CT Reports - AUC | 3 months after CT | \- Area under the receiver-operating-characteristic curve (AUC). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT01925014/registered