Trial · NCT01925014
Low vs. Standard Dose CT for Appendicitis Trial
NCT01925014, Not applicable, Completed, Kyoung Ho Lee, MD; results first posted 2019-01-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Low vs. Standard Dose CT for Appendicitis Trial. Trials, record NCT01925014. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01925014
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low vs. Standard Dose CT for Appendicitis Trial
- NCT number
- NCT01925014
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 3,074 participants, actual
- Lead sponsor
- Kyoung Ho Lee, MD
- Conditions
- Appendicitis
- Interventions
- Diagnostic CT with low-dose radiation, Diagnostic CT with standard-dose radiation
- First posted
- 2013-08-19
- Last updated
- 2019-01-31
- Results first posted
- 2019-01-31
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Negative Appendectomy Rate | 1 week after surgery | Patients who underwent appendectomy. Intention-to-treat. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Appendiceal Perforation Rate | 1 week after surgery | Patients confirmed as having appendicitis. Intention-to-treat. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Appendectomies | 3 months after CT | Intention-to-treat. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Negative Appendectomies | 1 week after surgery | Intention-to-treat. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Prevalence of Perforated Appendicitis | 1 week after surgery | Intention-to-treat. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Prevalence of Non-perforated Appendicitis | 1 week after surgery | Intention-to-treat. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Need for Additional Imaging Test(s) | 1 week after CT | Intention-to-treat. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Delay in Patient Disposition | 3 months after CT | Intention-to-treat. | Hours | MEDIAN |
| SECONDARY | Length of Hospital Stay Associated With Appendectomy | 3 months after CT | Patients who underwent appendectomy. Intention-to-treat. Interval appendectomies following percutaneous abscess drainage and/or medical treatment were not included in this analysis. | Days | MEDIAN |
| SECONDARY | Diagnostic Performance of CT Reports - AUC | 3 months after CT | Patients with incomplete reference standards were not included in these analyses. Intention-to-treat. | AUC | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Negative Appendectomy Rate | Low-dose CT | Negative appendectomy (NA) rate | 22 | Participants | |
| Negative Appendectomy Rate | Standard-dose CT | Negative appendectomy (NA) rate | 16 | Participants | |
| Negative Appendectomy Rate | Low-dose CT | Not counting appendiceal neoplasm(s) as NA | 21 | Participants | |
| Negative Appendectomy Rate | Standard-dose CT | Not counting appendiceal neoplasm(s) as NA | 16 | Participants | |
| Appendiceal Perforation Rate | Low-dose CT | 182 | Participants | ||
| Appendiceal Perforation Rate | Standard-dose CT | 176 | Participants | ||
| Number of Appendectomies | Low-dose CT | 559 | Participants | ||
| Number of Appendectomies | Standard-dose CT | 601 | Participants | ||
| Number of Negative Appendectomies | Low-dose CT | 22 | Participants | ||
| Number of Negative Appendectomies | Standard-dose CT | 16 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low-dose CT | 1,535 | |
| Overall Study | STARTED | Standard-dose CT | 1,539 | |
| Overall Study | COMPLETED | Low-dose CT | 1,526 | |
| Overall Study | COMPLETED | Standard-dose CT | 1,520 | |
| Overall Study | NOT COMPLETED | Low-dose CT | 9 | |
| Overall Study | NOT COMPLETED | Standard-dose CT | 19 |
Source ClinicalTrials.gov
Adverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Low-dose CT | 0 | 1,535 | 0 |
| serious | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Standard-dose CT | 1 | 1,539 | 1 |
| serious | Leukocytosis | Blood and lymphatic system disorders | Low-dose CT | 1 | 1,535 | 1 |
| serious | Leukocytosis | Blood and lymphatic system disorders | Standard-dose CT | 0 | 1,539 | 0 |
| serious | Abdominal pain | Gastrointestinal disorders | Low-dose CT | 6 | 1,535 | 6 |
| serious | Abdominal pain | Gastrointestinal disorders | Standard-dose CT | 8 | 1,539 | 8 |
| serious | Diarrhea | Gastrointestinal disorders | Low-dose CT | 0 | 1,535 | 0 |
| serious | Diarrhea | Gastrointestinal disorders | Standard-dose CT | 1 | 1,539 | 1 |
| serious | Enterocolitis | Gastrointestinal disorders | Low-dose CT | 4 | 1,535 | 4 |
| serious | Enterocolitis | Gastrointestinal disorders | Standard-dose CT | 0 | 1,539 | 0 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low-dose CT | 0 | 1,535 |
| Total, all-cause mortality | Standard-dose CT | 0 | 1,539 |
| Total, other adverse events | Low-dose CT | 0 | 1,535 |
| Total, other adverse events | Standard-dose CT | 0 | 1,539 |
| Total, serious adverse events | Low-dose CT | 43 | 1,535 |
| Total, serious adverse events | Standard-dose CT | 40 | 1,539 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Low-dose CT vs Standard-dose CT: Number of Negative Appendectomies | Trial comparisons |
| Low-dose CT vs Standard-dose CT: Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Indeterminate Interpretation (Grade 3) | Trial comparisons |
| Low-dose CT vs Standard-dose CT: Number of Appendectomies | Trial comparisons |
| Low-dose CT vs Standard-dose CT: Appendiceal Perforation Rate | Trial comparisons |
| Low-dose CT vs Standard-dose CT: Prevalence of Perforated Appendicitis | Trial comparisons |
| Low-dose CT vs Standard-dose CT: Prevalence of Non-perforated Appendicitis | Trial comparisons |
| Low-dose CT vs Standard-dose CT: Need for Additional Imaging Test(s) | Trial comparisons |
| Low-dose CT vs Standard-dose CT: deaths from any cause | Trial comparisons |
| Low-dose CT vs Standard-dose CT: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01925014
GET https://conductscience.org/api/trials/v1/NCT01925014/results?page=2