Status Approved
First Submitted Date
2019/12/05
Registered Date
2019/12/12
Last Updated Date
2019/12/05
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004545 |
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Unique Protocol ID | CR319126 |
Public/Brief Title | Abdominal computed tomography findings requiring surgery in the absence of solid organ damage in patients with abdominal blunt trauma |
Scientific Title | Findings requiring immediate surgery in blunt abdominal trauma patients with isolated free fluid without solid organ injury on abdominal computed tomography: Clinical and radiologic analysis |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | CR319126 |
Approval Date | 2019-11-05 |
Institutional Review Board Name | Yonsei University Wonju Severance Christian Hospital Institutional Review Board |
Institutional Review Board Address | 20, Ilsan-ro, Wonju-si, Gangwon-do |
Institutional Review Board Telephone | 033-741-1703 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Seongyup Kim |
Title | MD |
Telephone | +82-33-741-0884 |
Affiliation | Yonsei University, Wonju Severance Christian Hospital |
Address | Gangwondo Wonju city, Ilsanro 20 |
Contact Person for Public Queries | |
Name | Seongyup Kim |
Title | MD |
Telephone | +82-33-741-0884 |
Affiliation | Yonsei University, Wonju Severance Christian Hospital |
Address | Gangwondo Wonju city, Ilsanro 20 |
Contact Person for Updating Information | |
Name | Seongyup Kim |
Title | MD |
Telephone | +82-33-741-0884 |
Affiliation | Yonsei University, Wonju Severance Christian Hospital |
Address | Gangwondo Wonju city, Ilsanro 20 |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2019-11-05 Actual | |
Target Number of Participant | 56 | |
Primary Completion Date | 2019-12-04 , Actual | |
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Yonsei University, Wonju Severance Christian Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2019-11-05 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Yonsei University, Wonju Severance Christian Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yonsei University, Wonju Severance Christian Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | In patients with abdominal blunt trauma, abdominal computed tomography does not have solid organ damage and fluid retention in the abdominal cavity often results in intestinal or mesenteric damage requiring surgery. However, there are not many cases where surgery is not necessary, so it is very important to distinguish between these two situations in order to reduce unnecessary surgery. The purpose of this study was to identify the clinical and radiologic factors to find out when surgery was needed. For this purpose, the medical records and images of patients were retrospectively analyzed. During the analysis, the patient's personal information was blocked to prevent exposure to researchers and article resulted from this study. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-control |
Time Perspective | Retrospective |
Target Number of Participant | 56 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Blunt abdominal trauma patients |
Cohort/Group Description Patients treated at our government-established regional tertiary trauma center between March 2014 and August 2018. A total of 13,167 patients had a diagnosis of abdominal trauma |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Patients treated at our government-established regional tertiary trauma center between March 2014 and August 2018. A total of 13,167 patients had a diagnosis of abdominal trauma |
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Sampling Method | Medical records of abdominal blunt patients who underwent abdominal computed tomography were identified through analysis of medical records under the diagnosis name (abdominal injuries) in the institution's own patient registry during the study period. |
Condition(s)/Problem(s) |
* (S00-T98)Injury, poisoning and certain other consequences of external causes (S39.9)Unspecified injury of abdomen, lower back and pelvis abdominal blunt trauma |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age No Limit~No Limit |
|
Description All abdominal blunt patients who underwent abdominal computed tomography at Wonju Severance Christian Hospital from March 2014 to August 2018. |
|
Exclusion Criteria |
a retroperitoneal hematoma; genitourinary tract injury except bladder injury; solid organ injury; penetrating injury. |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | the need of surgery |
|
Timepoint | at discharge |
|
Secondary Outcome(s) 1 | ||
Outcome | complication |
|
Timepoint | at discharge |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2020. 9 |
Way of Sharing | Available on Request
(sykimvs@yonsei.ac.kr) |
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