Back to resultsRobot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Radical prostatectomy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring laparoscopic radical prostatectomy, robotic-assisted laparoscopic radical prostatectomy, prostate cancer
Eligibility Criteria
Inclusion Criteria:
- Adult men aged 18 years and over;
- Undergoing RARP or LRP. prostatectomy for prostate cancer at Binh Dan Hospital;
- Clinically suitable for radical prostatectomy (cT1-3, No, Mo);
- Cognitively able to give written informed consent for participation;
- Elective procedure.
Exclusion Criteria:
- The patient lacks the ability to consent for themselves;
- Patients unwilling to undergo pre- and post-operative evaluation according to the protocol;
Sites / Locations
- Binh Dan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Robotic-assisted surgery
Laparoscopic surgery
Arm Description
Outcomes
Primary Outcome Measures
The console time
The time which surgeon spends on the robot console by minuite
Mean of blood loss
Milliliter
Perioperative transfusion rate (%)
The number of cases which will be transfused.
The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,
Number of cases, based on the result of pathology.
Number of blood units transfused
Milliliter
the rate of conversion to open surgery, the rate of intraoperative incidents (%),
Percentage
The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, in a total of 10 points, higher score means worse, with 0 means no pain and 10 is the worst pain. The mean score will be calculated to reflect the post-operative pain.
Change of hemoglobin from baseline
(mg/mL)
The drainage time
(day),
To assess urethral catheter time, urethral catheter time
(day)
To assess bowel movement recovery time,
(day)
To assess postoperative hospital stay
(day)
The rate of postoperative complications (including infections)
Percentage
PSA level in blood
(mg/mL)
PSA level in blood
(mg/mL)
PSA level in blood
(mg/mL)
PSA level in blood
(mg/mL)
PSA level in blood
(mg/mL)
local and regional recurrences on sonography
including ultrasound when PSA rising or any indication of recurrent
local and regional recurrences, on MRI
including MRI when PSA rising or any indication of recurrent
local and regional recurrences, on PET Scan
including PET Scan, when PSA rising or any indication of recurrent
Secondary Outcome Measures
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04011865
Brief Title
Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
Official Title
Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Binh Dan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to compare the outcomes of robotic-assisted laparoscopic radical prostatectomy (RARP) and laparoscopic radical prostatectomy (LRP) for prostate cancer treatment in terms of perioperative surgical, functional and oncological outcomes.
Detailed Description
Participants will either have robotic-assisted laparoscopic radical prostatectomy (RARP) or laparoscopic radical prostatectomy (LRP) as determined by the treating surgeon. All participants will undergo tests and questionnaires to determine urinary and erectile function, biopsies to determine perioperative surgical, functional and oncological outcomes. These assessments will be conducted pre-operatively, post-operatively and at certain follow-up time points up to 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
laparoscopic radical prostatectomy, robotic-assisted laparoscopic radical prostatectomy, prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robotic-assisted surgery
Arm Type
Active Comparator
Arm Title
Laparoscopic surgery
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Radical prostatectomy
Intervention Description
The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
Primary Outcome Measure Information:
Title
The console time
Description
The time which surgeon spends on the robot console by minuite
Time Frame
During the surgery
Title
Mean of blood loss
Description
Milliliter
Time Frame
During the surgery
Title
Perioperative transfusion rate (%)
Description
The number of cases which will be transfused.
Time Frame
Up to 1 month after operation
Title
The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,
Description
Number of cases, based on the result of pathology.
Time Frame
Up to 1 week after operation
Title
Number of blood units transfused
Description
Milliliter
Time Frame
Up to 1 week after operation
Title
the rate of conversion to open surgery, the rate of intraoperative incidents (%),
Description
Percentage
Time Frame
Up to 1 weeks after the surgery.
Title
The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),
Description
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, in a total of 10 points, higher score means worse, with 0 means no pain and 10 is the worst pain. The mean score will be calculated to reflect the post-operative pain.
Time Frame
Up to 3 month after surgery
Title
Change of hemoglobin from baseline
Description
(mg/mL)
Time Frame
Up to 1 week after operation
Title
The drainage time
Description
(day),
Time Frame
Up to 3 months after surgery
Title
To assess urethral catheter time, urethral catheter time
Description
(day)
Time Frame
Up to 3 months after surgery
Title
To assess bowel movement recovery time,
Description
(day)
Time Frame
Up to 1 week after surgery
Title
To assess postoperative hospital stay
Description
(day)
Time Frame
Up to 1 month after surgery
Title
The rate of postoperative complications (including infections)
Description
Percentage
Time Frame
in day 3, day 7, and 1 month after surgery.
Title
PSA level in blood
Description
(mg/mL)
Time Frame
Before operation
Title
PSA level in blood
Description
(mg/mL)
Time Frame
6 weeks post-operation
Title
PSA level in blood
Description
(mg/mL)
Time Frame
3 months post-operation
Title
PSA level in blood
Description
(mg/mL)
Time Frame
6 months post-operation
Title
PSA level in blood
Description
(mg/mL)
Time Frame
12 months post-operation
Title
local and regional recurrences on sonography
Description
including ultrasound when PSA rising or any indication of recurrent
Time Frame
through study completion, an average of 1 year
Title
local and regional recurrences, on MRI
Description
including MRI when PSA rising or any indication of recurrent
Time Frame
through study completion, an average of 1 year
Title
local and regional recurrences, on PET Scan
Description
including PET Scan, when PSA rising or any indication of recurrent
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Description
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
Time Frame
Preoperative
Title
Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)
Description
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
Time Frame
3 months postoperative
Title
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Description
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
Time Frame
6 months, postoperative
Title
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Description
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life. The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points. The sum score will be calculated and the mean score will be evaluated.
Time Frame
12 months postoperative.
Title
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Description
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.
Time Frame
Preoperative
Title
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Description
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.
Time Frame
3 months, postoperative
Title
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Description
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.
Time Frame
6 months, postoperative.
Title
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Description
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity). The mean score will be calculated.
Time Frame
12 months postoperative
Title
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.
Time Frame
Preoperative
Title
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.
Time Frame
3 months, postoperative.
Title
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.
Time Frame
6 months, postoperative
Title
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The mean score will be calculated.
Time Frame
12 months postoperative
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult men aged 18 years and over;
Undergoing RARP or LRP. prostatectomy for prostate cancer at Binh Dan Hospital;
Clinically suitable for radical prostatectomy (cT1-3, No, Mo);
Cognitively able to give written informed consent for participation;
Elective procedure.
Exclusion Criteria:
The patient lacks the ability to consent for themselves;
Patients unwilling to undergo pre- and post-operative evaluation according to the protocol;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hoang PC Nguyen, Associate Professor, MD, PhD
Phone
+84 913 719 346
Email
npchoang@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Linh NK Tran, MD, PhD
Phone
+84 989 047 088
Email
khaclinh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung V Tran, MD, PhD
Organizational Affiliation
Binh Dan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Binh Dan Hospital
City
Ho Chi Minh City
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hoang PC Nguyen, Associate Professor, MD, PhD
Phone
+84 913 719 346
Email
npchoang@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
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