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Clinical outcomes and effect of delayed intervention in patients with small bowel perforation due to blunt abdominal trauma: A retrospective, observational analysis

Status Approved

  • First Submitted Date

    2019/12/27

  • Registered Date

    2020/01/23

  • Last Updated Date

    2020/01/08

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
    KCT0004644
    Unique Protocol ID HP IRB 2019-05-002-001
    Public/Brief Title Clinical outcomes and effect of delayed intervention in patients with small bowel perforation due to blunt abdominal trauma: A retrospective, observational analysis
    Scientific Title Clinical outcomes and effect of delayed intervention in patients with small bowel perforation due to blunt abdominal trauma: A retrospective, observational analysis
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    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 HP IRB 2019-05-002-001
    Approval Date 2019-10-21
    Institutional Review Board Name Inje University Haeundae Paik Hospital IRB
    Institutional Review Board Address 875, Haeun-daero, Haeundae-gu, Busan
    Institutional Review Board Telephone 051-797-2747
    Data Monitoring Committee No
  • 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 Ki Hoon Kim
    Title Associate prof.
    Telephone +82-51-797-0522
    Affiliation Inje University Haeundae Paik Hospital
    Address 875, Haeundaero, Haeundaegu, Busan, Korea
    Contact Person for Public Queries
    Name Ki Hoon Kim
    Title Associate prof.
    Telephone +82-51-797-0522
    Affiliation Inje University Haeundae Paik Hospital
    Address 875, Haeundaero, Haeundaegu, Busan, Korea
    Contact Person for Updating Information
    Name Ki Hoon Kim
    Title Associate prof.
    Telephone +82-51-797-0522
    Affiliation Inje University Haeundae Paik Hospital
    Address 875, Haeundaero, Haeundaegu, Busan, Korea
  • 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 Active, not recruiting
    Date of First Enrollment 2019-10-22 Actual
    Target Number of Participant 52
    Primary Completion Date 2019-11-21 , Actual
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Inje University Haeundae Paik Hospital
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2019-10-22 ,
  • 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 Inje University Haeundae Paik Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Inje University Haeundae Paik Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Small bowel injury is reportedly the third most common injury in blunt abdominal trauma. As reported in a previous multicentric study, it was diagnosed in 1.1% of patients admitted with a history of blunt abdominal trauma, of which, only 0.3% patients were found to have a small bowel perforation. Investigations including abdominal X-ray, ultrasonography, peritoneal lavage, computed tomography (CT), and exploratory laparoscopy have been traditionally used to evaluate the extent of injuries following blunt abdominal trauma. CT is the currently accepted standard imaging modality, not only for the diagnosis of an abdominal solid organ injury, but also for evaluating suspected trauma involving hollow viscera, in an otherwise hemodynamically stable patient. The abdominal radiographic findings most often correlated with a diagnosis of small bowel injury include the presence of free intraperitoneal gas or fluid, enhanced bowel-wall thickness, mesenteric fat stranding, and detection of extra-luminal gas. Initial CT scan failed to detect ~15% of small bowel injures, though it has been found to be efficient and accurate for evaluating blunt trauma patients. There is still controversy surrounding the topic of how reliably CT by itself could help identify a blunt injury to the bowel that required surgical repair. The low incidence of small bowel injury and difficulty in diagnosis can result in delayed surgical intervention. A diagnostic delay of >24 h correspondingly increases morbidity and mortality due to the injury. While certain studies have suggested an association between increased morbidity and mortality and a diagnostic wait of even <5-8 h, some other reports claim that a delay in either the diagnosis or treatment of blunt bowel injury does not correlate with an increased incidence of subsequent complications. The purpose of this study was to determine whether the time-interval to operative treatment had any impact on the outcomes of patients who underwent surgery for blunt small bowel perforation. We performed not only a comparative analysis based on an 8-h delay, but also evaluated treatment outcomes in patients operated after a 24-h interval. 
    This study was approved by the Research Ethics Board of my hospital. The data of all adult patients presenting with blunt abdominal injury, identified through the trauma database of a single regional hospital between March 2010 and December 2018, were collated for the study. The inclusion criteria were age >18 years and admission to the emergency department for blunt abdominal trauma during the study period. Data of patients who did not undergo abdominal organ surgery, who expired in <1 day of admission, for whom an abdominopelvic CT scan was not performed on admission in the ED, who underwent other abdominal organ repair in the presence or absence of associated small bowel injury, and who were operated only for mesenteric repair were excluded from the study. Finally, the study patients were divided into 3 groups of ≤8 h, 8-24 h, and >24 h, depending on the time-interval between injury and receiving operative intervention. And the outcome was also analyzed by divided into 2 groups of ≤24h and >24h according to time interval. Relevant variable factors were compared in each group. All patients’ hospital charts as well as their information from the database were reviewed and analyzed. Utilizing the ED database, every patient’s particulars including demographic characteristics, mechanism of injury, admission GCS score, time-interval from injury to OR transfer, time-interval between transfer from ED to OR, AIS code, ISS, clinical examination findings, laboratory and CT results, BIPS, whether small bowel resection was performed during operative abdominal exploration, LOS, ICU LOS, and mortality and morbidity data were identified and collated. Mortality was defined as death occurring at any time during the entire LOS, after the first 24 h of hospitalization. The recorded clinical findings include
  • 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-only
    Time Perspective Retrospective  
    Target Number of Participant 52
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    blunt trauma small bowel perforation patient

    Cohort/Group Description

    The data of all adult patients presenting with blunt abdominal injury, identified through the trauma database of a single regional hospital between March 2010 and December 2018, were collated for the study. The inclusion criteria were age >18 years and admission to the emergency department for blunt abdominal trauma during the study period. Data of patients who did not undergo abdominal organ surgery, who expired in <1 day of admission, for whom an abdominopelvic CT scan was not performed on admission in the ED, who underwent other abdominal organ repair in the presence or absence of associated small bowel injury, and who were operated only for mesenteric repair were excluded from the study. Finally, the study patients were divided into 3 groups of ≤8 h, 8-24 h, and >24 h, depending on the time-interval between injury and receiving operative intervention. And the outcome was also analyzed by divided into 2 groups of ≤24h and >24h according to time interval. Relevant variable factors were compared in each group
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    The data of all adult patients presenting with blunt abdominal injury, identified through the trauma database of a single regional hospital between March 2010 and December 2018, were collated for the study.
    Sampling Method
    According to non-probablity sampling, the inclusion criteria were age >18 years and admission to the emergency department for blunt abdominal trauma during the study period. Data of patients who did not undergo abdominal organ surgery, who expired in <1 day of admission, for whom an abdominopelvic CT scan was not performed on admission in the emergency department (ED), who underwent other abdominal organ repair in the presence or absence of associated small bowel injury, and who were operated only for mesenteric repair were excluded from the study. Finally, the study patients were divided into 3 groups of ≤8 h, 8-24 h, and >24 h, depending on the time-interval between injury and receiving operative intervention
    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 

    Blunt abdominal trauma; Small bowel perforation; delayed intervention
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~100Year

    Description

    age >18 years and admission to the emergency department for blunt abdominal trauma
    Exclusion Criteria
    who did not undergo abdominal organ surgery, who expired in <1 day of admission, for whom an abdominopelvic CT scan was not performed on admission in the emergency department (ED), who underwent other abdominal organ repair in the presence or absence of associated small bowel injury, and who were operated only for mesenteric repair were excluded from the study.
    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 clinical-equivalence
    Primary Outcome(s) 1
    Outcome
    clinical outcome(morbidity, mortality)
    Timepoint
    time of discharge
    Secondary Outcome(s) 1
    Outcome
    analysis of baseline chanracteristics, outcome of surgery
    Timepoint
    time of 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 No
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