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Changes in blood viscosity in patients undergoing robot-assisted laparoscopic prostatectomy with steep Trendelenburg position

Status Approved

  • First Submitted Date

    2018/09/17

  • Registered Date

    2018/10/25

  • Last Updated Date

    2019/04/10

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
    KCT0003295
    Unique Protocol ID KC18OESI0540
    Public/Brief Title Changes in blood viscosity in patients undergoing robot-assisted laparoscopic prostatectomy with steep Trendelenburg position
    Scientific Title Changes in blood viscosity in patients undergoing robot-assisted laparoscopic prostatectomy with steep Trendelenburg position
    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 KC18OESI0540
    Approval Date 2018-09-06
    Institutional Review Board Name Seoul St. Mary's Hospital - Institutional Review Board
    Institutional Review Board Address 222, Banpo-daero, Seocho-gu, Seoul
    Institutional Review Board Telephone 02-2258-8202
    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 Min Suk Chae
    Title Doctor
    Telephone +82-2-2258-6150
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address Department of Anethesoiolgy and Pain medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea
    Contact Person for Public Queries
    Name Min Suk Chae
    Title Doctor
    Telephone +82-2-2258-6150
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address Department of Anethesoiolgy and Pain medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea
    Contact Person for Updating Information
    Name Min Suk Chae
    Title Doctor
    Telephone +82-2-2258-6150
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address Department of Anethesoiolgy and Pain medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul, 06591, 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 2018-09-07 Actual
    Target Number of Participant 60
    Primary Completion Date 2019-02-28 , Actual
    Study Completion Date 2019-02-28 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study The Catholic University of Korea, Seoul St. Mary's Hospital
    Recruitment Status Completed
    Date of First Enrollment 2018-09-07 ,
  • 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 The Catholic University of Korea, Seoul St. Mary's Hospital
    Organization Type University
    Project ID KC18OESI0540
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name The Catholic University of Korea, Seoul St. Mary's Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Blood viscosity has been considered in many studies as a major risk factor or a reliable predictor of cardiovascular or cerebrovascular disease. This blood viscosity is determined by the complex action of blood components, including red blood cells, white blood cells, platelets, fibrinogen, and various blood proteins. In particular, platelets and fibrinogen play an important role in the aggregation of red blood cells, which results in disturbance of peripheral blood circulation. Blood viscosity is greatly increased in diseases such as myocardial infarction and stroke, and efforts are made to decrease the number or function of hematocrit or fibrinogen as a treatment method to reduce blood viscosity. Thus, blood viscosity is an important factor closely related to the adequacy of blood circulation in patients.
     Patients diagnosed with prostate cancer have been treated with robotic laparoscopic surgery for less tissue damage than conventional prostate cancer surgery. However, robotic laparoscopic surgery requires a steep head down posture in addition to penumoperitoneum in order to obtain an operative visual field. In addition, patients with older and various comorbidity (ie, diabetes, hypertension, and angina) have undergone robotic laparoscopic surgery due to good outcomes after the surgery. These patients are expected to increase even more in the future.
     In conclusion, this study examines the changes in blood viscosity of patients during surgery and finds factors associated with increased blood viscosity. This will be an important data to reduce the risk of sudden increase in blood viscosity during surgery.
  • 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 60
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Patients undergoing robot-assisted laparoscopic prostatectomy with steep Trendelenburg position

    Cohort/Group Description

    Blood viscosity is measured three times during surgery that are immediately after anesthesia; after surgical position (i.e., steep Trendelenburg position with pneumoperitoneum); and immediately after perioneal closure in supine position in patients undergoing robot-assisted laparoscopic prostatectomy with steep Trendelenburg position
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    patients undergoing robot-assisted laparoscopic prostatectomy in Seoul St. Mary's hospital, 19 or more years old, ASA 1 or 2 group
    Sampling Method
    Based on the number of 200 adult patients who underwent robotic-assisted laparoscopic prostate cancer surgery at Seoul St. Mary's Hospital from january 1, 2017 to December 31, 2017, we will collect 60 patient data and conduct a pilot study to investigate intraoperative changes in blood viscosity using simple random sampling.
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C61)Malignant neoplasm of prostate 

    Prostatic Neoplasms
    Rare Disease No
    Inclusion Criteria

    Gender

    Male

    Age

    19Year~No Limit

    Description

    1. Robotic-assisted laparoscopic prostate cancer surgery at Seoul St. Mary's Hospital
    2. Adults (age more than 19 years-old)
    3. American Society of Anesthesiologists grade 1 or 2
    Exclusion Criteria
    1. Disagreement to participate in this study
    2. Emergency surgery
    3. Children (under 19 years old)
    4. American Society of Anesthesiologists grade 3, 4 or 5
    5. Massive hemorrhage to require colloid infusion or blood transfusion during surgery
    6. Severe hemodynamic instability to require vasopressors infusion during surgery
    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/Efficacy
    Primary Outcome(s) 1
    Outcome
    Blood viscosity
    Timepoint
    1. Immediately after general anesthesia (Supine position); 2. 30 minute after surgical position (Steep Trendelenburg position with pneumoperitoneum); 3 . Immediately before surgery (Supine position)
    Secondary Outcome(s) 1
    Outcome
    Correlations of intraoperative blood viscosity with preoperative clinical factors, such as gender, age, height, weight, body mass index, diabetes mellitus, hypertension, hepatitis, tuberculosis, abdominal surgical history, smoking history, prostate cancer stage, white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, neutrophil, lymphocyte, monocyte, eosinophil, basophil, MCV, MCH, MCHC, glucose, urea nitrogen, creatinine, total protein, albumin, AST, ALT, alkaline phosphatase, total bilirubin, uric acid, calcium, sodium, potassium, chloride, total cholesterol, triglyceride, HDL, LDL, prothrombin time, international normalized ratio, activated partial thrombin time, fibrinogen, D-dimer, FDP
    Timepoint
    Date of the final analysis of the data
    Secondary Outcome(s) 2
    Outcome
    Correlations of intraoperative blood viscosity with intraoperative clinical factors, such as total surgery duration, total amount of fluid infusion, toal urine output, blood pressure, heart rate, body temperature, central venous pressure
    Timepoint
    Date of the final analysis of the data
    Secondary Outcome(s) 3
    Outcome
    all-causes morbidity and mortality; and total hospital administration duration
    Timepoint
    During hospital administration after the surgery
  • 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 Not provided at time of Registration
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