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Comparison of postoperative outcomes of general versus neuroaxial anesthesia in elderly patients undergoing hip fracture surgery using Korean nationwide claims data

Status Approved

  • First Submitted Date

    2018/02/20

  • Registered Date

    2018/05/18

  • Last Updated Date

    2018/04/26

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
    KCT0002884
    Unique Protocol ID 201704350001
    Public/Brief Title Comparison of postoperative outcomes of general versus neuroaxial anesthesia in elderly patients undergoing hip fracture surgery using Korean nationwide claims data
    Scientific Title Comparison of postoperative outcomes of general versus neuroaxial anesthesia in elderly patients undergoing hip fracture surgery using Korean nationwide claims data
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted exempt
    Board Approval Number PAIK 2018-04-007
    Approval Date 2017-07-18
    Institutional Review Board Name Institutional Review Board of Inje University Seoul Paik Hospital
    Institutional Review Board Address 9, Mareunnae-ro, Jung-gu, Seoul
    Institutional Review Board Telephone 02-2270-0945
    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 SI RA BANG
    Title MD,PhD
    Telephone +82-2-2270-0094
    Affiliation Inje University Seoul Paik Hospital
    Address 2-Ga Jeo-dong, Jung-Gu, Seoul, Republic of Korea
    Contact Person for Public Queries
    Name SI RA BANG
    Title MD,PhD
    Telephone +82-2-2270-0094
    Affiliation Inje University Seoul Paik Hospital
    Address 2-Ga Jeo-dong, Jung-Gu, Seoul, Republic of Korea
    Contact Person for Updating Information
    Name SI RA BANG
    Title MD,PhD
    Telephone +82-2-2270-0094
    Affiliation Inje University Seoul Paik Hospital
    Address 2-Ga Jeo-dong, Jung-Gu, Seoul, Republic of 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 2017-08-01 Actual
    Target Number of Participant 100000
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Inje University
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2017-08-01 ,
  • 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 National Research Foundation
    Organization Type Government
    Project ID 201704350001
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Inje University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Aging population are fast growing especially in developed country. South Korea is one of the rapid changing society of elderly population which represents as aged society that defined as an elderly population is more than14%  of the total population. Ha et al. reported that hip fracture incidence continues to increase, and the predicted increases will be a serious socioeconomic burden and a challenge for public health care managements in Korea.  Hip fracture is usually associated with adverse complications including mortality that resulted medical and financial burden for the society.
    One of the most common and adverse complication of elderly hip fracture patients is delirium. It is associated increased rate of cognitive decline, institutionalization, and mortality. 
    To decrease the mortality rate and postoperative delirium one of recommendation is choice of anesthesia method. Mode of anesthesia related mortality and outcome in geriatric patients are debated questions. There are some reports that most of the anesthesia related complication are multifactorial. However, in hip fracture surgery there are some reports that RA represents favorable outcome. We used nationwide database to evaluate the effects of anesthesia on postoperative outcome 
    The primary outcome of this study was to evaluate the anesthetic method affect 30 day in hospital mortality in hip fracture surgery using nationwide database. Furthermore, we compared postoperative delirium which needed pharmacological intervention between general anesthesia and regional anesthesia.
  • 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 Others
    Time Perspective Retrospective  
    Target Number of Participant 100000
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    patients undergoing hip fracture surgery aged older than 65 years under general anesthesia

    Cohort/Group Description

    all patients undergoing hip fracture surgery aged 65 years and older admitted to hospitals in Korea . The major inclusion criterion was admission with a principal diagnosis of femur neck fracture(S720) and trochanteric fracture(S721) as identified through the patient’s principal diagnosis recorded using the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) code. We included those admissions who underwent at least one of the following surgical operations based on ICD-10-CM procedure codes: N0601, N0611, N0711, N2070, N0715, N2710, N1715, N4710, N1725, N4720. We included who received general anesthesia.
    Cohort/
    Group 2

    Cohort/Group Label

    patients undergoing hip fracture surgery aged older than 65 years under regional anesthesia

    Cohort/Group Description

    all patients undergoing hip fracture surgery aged 65 years and older admitted to hospitals in Korea . The major inclusion criterion was admission with a principal diagnosis of femur neck fracture(S720) and trochanteric fracture(S721) as identified through the patient’s principal diagnosis recorded using the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) code. We included those admissions who underwent at least one of the following surgical operations based on ICD-10-CM procedure codes: N0601, N0611, N0711, N2070, N0715, N2710, N1715, N4710, N1725, N4720. We included who received regional(spinal and epidural) anesthesia.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    patients undergoing hip fracture surgery aged 65 years and older admitted to hospitals in Korea using national health insurance claims data
    Sampling Method
    principal diagnosis of femur neck fracture(S72.0) and trochanteric fracture(S72.1) as identified through the patient’s principal diagnosis recorded using the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) code. We included those admissions who underwent at least one of the following surgical operations based on ICD-10-CM procedure codes: N0601, N0611, N0711, N2070, N0715, N2710, N1715, N4710, N1725, N4720.
    Condition(s)/Problem(s) * (S00-T98)Injury, poisoning and certain other consequences of external causes 
       (S72.080)Fracture of other parts of neck of femur, closed 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    65Year~No Limit

    Description

    principal diagnosis of femur neck fracture(S72.0) and trochanteric fracture(S72.1) as identified through the patient’s principal diagnosis recorded using the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) code. We included those admissions who underwent at least one of the following surgical operations based on ICD-10-CM procedure codes: N0601, N0611, N0711, N2070, N0715, N2710, N1715, N4710, N1725, N4720. We included who received general, spinal and epidural anesthesia.
    Exclusion Criteria
    We excluded patients who received both general and regional anesthesia. For patients with diagnosis of multiple trauma or fracture ('S00-S70', 'S73-99', 'T07', 'T14') were excluded. Also, we excluded patients who underwent more than twice of the operations during the same period of admission.
    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 Safety
    Primary Outcome(s) 1
    Outcome
    Thirty-day mortality
    Timepoint
    postoperative 30 days
    Secondary Outcome(s) 1
    Outcome
    occurrence of delirium
    Timepoint
    at least once during the indexed administration period
  • 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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