Records View

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

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

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004545
    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

    Institutional Review Board Information
    Board Approval Status Submitted approval
    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 Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific 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 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

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Yonsei University, Wonju Severance Christian Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University, Wonju Severance Christian Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    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.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    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

    Subject Eligibility Information
    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
    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)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    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

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2020. 9
    Way of Sharing Available on Request
    (sykimvs@yonsei.ac.kr)
화면 최상단으로 이동

TOP

BOTTOM

화면 최하단으로 이동