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
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
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 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
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
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
1. Sponsor Organization | |
---|---|
Organization Name | The Catholic University of Korea, Seoul St. Mary's Hospital |
Organization Type | Medical Institute |
7. Study Summary
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 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
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)
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
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
---|
TOP
BOTTOM
화면 최하단으로 이동