연구정보 영문

Association of preoperative diaphragm function with postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic prostatectomy

Status Approved

  • First Submitted Date

    2020/05/15

  • Registered Date

    2020/05/18

  • Last Updated Date

    2020/10/22

  • 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
    KCT0005028
    Unique Protocol ID 2020-0761
    Public/Brief Title Association of preoperative diaphragm function with postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic prostatectomy
    Scientific Title Association of preoperative diaphragm function with postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic prostatectomy
    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 2020-0761
    Approval Date 2020-05-15
    Institutional Review Board Name Asan Medical Center Institutional Review Board
    Institutional Review Board Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul
    Institutional Review Board Telephone 02-3010-7166
    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 Young-Kug Kim
    Title Professor
    Telephone +82-2-3010-5976
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea
    Contact Person for Public Queries
    Name Jihion Yu
    Title Clinical instructor
    Telephone +82-2-3010-3868
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea
    Contact Person for Updating Information
    Name Jihion Yu
    Title Clinical instructor
    Telephone +82-2-3010-3868
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43-gil, Songpa-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 Completed
    Date of First Enrollment 2020-05-20 Actual
    Target Number of Participant 145
    Primary Completion Date 2020-09-19 , Actual
    Study Completion Date 2020-09-19 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Asan Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2020-05-20 ,
  • 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 Asan Medical Center
    Organization Type Medical Institute
    Project ID 2020-0761
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Asan Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    We will investigate the relationship between preoperative diaphragm function and postoperative pulmonary complications in prostate cancer patients undergoing robotic-assisted laparoscopic prostatectomy.
  • 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 Cohort
    Time Perspective Prospective  
    Target Number of Participant 145
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Robotic-assisted laparoscopic prostatectomy group

    Cohort/Group Description

    The diaphragm thickening fraction is measured using ultrasound before induction of anesthesia in patients undergoing robotic-assisted laparoscopic prostatectomy.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Prostate cancer patients between 20 and 79 years old who will undergo robotic-assisted laparoscopic prostatectomy
    Sampling Method
    Non-probablity sampling: consequent sampling
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C61)Malignant neoplasm of prostate 

    Prostatic neoplasms
    Rare Disease No
    Inclusion Criteria

    Gender

    Male

    Age

    20Year~79Year

    Description

    Prostate cancer patients between 20 and 79 years old who will undergo robotic-assisted laparoscopic prostatectomy
    American Society of Anesthesiologist Physical Status1 - 3
    Paitents who voluntarily consent to participate in this study
    Exclusion Criteria
    Patients who refuse to participate in this study
    Patients who underwent pneumonectomy
    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
    Incidence of postoperative pulmonary complicaions
    Timepoint
    During postoperative 7 days
    Secondary Outcome(s) 1
    Outcome
    Hostpital stay
    Timepoint
    At discharge day
    Secondary Outcome(s) 2
    Outcome
    ICU admission rate
    Timepoint
    During hospitalization
  • 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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