Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
2020年7月12日 更新者：Binh Dan Hospital
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Ho Chi Minh City、越南、700000
- 招聘中
- Binh Dan Hospital
-
接触：
- Hoang PC Nguyen, Associate Professor, MD, PhD
- 电话号码：+84 913 719 346
- 邮箱：npchoang@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
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;
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Robotic-assisted surgery
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The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
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假比较器：Laparoscopic surgery
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The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The console time
大体时间：During the surgery
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The time which surgeon spends on the robot console by minuite
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During the surgery
|
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Mean of blood loss
大体时间：During the surgery
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Milliliter
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During the surgery
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Perioperative transfusion rate (%)
大体时间：Up to 1 month after operation
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The number of cases which will be transfused.
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Up to 1 month after operation
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The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,
大体时间：Up to 1 week after operation
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Number of cases, based on the result of pathology.
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Up to 1 week after operation
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Number of blood units transfused
大体时间：Up to 1 week after operation
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Milliliter
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Up to 1 week after operation
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the rate of conversion to open surgery, the rate of intraoperative incidents (%),
大体时间：Up to 1 weeks after the surgery.
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Percentage
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Up to 1 weeks after the surgery.
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The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),
大体时间：Up to 3 month after surgery
|
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.
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Up to 3 month after surgery
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Change of hemoglobin from baseline
大体时间：Up to 1 week after operation
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(mg/mL)
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Up to 1 week after operation
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The drainage time
大体时间：Up to 3 months after surgery
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(day),
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Up to 3 months after surgery
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To assess urethral catheter time, urethral catheter time
大体时间：Up to 3 months after surgery
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(day)
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Up to 3 months after surgery
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To assess bowel movement recovery time,
大体时间：Up to 1 week after surgery
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(day)
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Up to 1 week after surgery
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To assess postoperative hospital stay
大体时间：Up to 1 month after surgery
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(day)
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Up to 1 month after surgery
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The rate of postoperative complications (including infections)
大体时间：in day 3, day 7, and 1 month after surgery.
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Percentage
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in day 3, day 7, and 1 month after surgery.
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PSA level in blood
大体时间：Before operation
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(mg/mL)
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Before operation
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PSA level in blood
大体时间：6 weeks post-operation
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(mg/mL)
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6 weeks post-operation
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PSA level in blood
大体时间：3 months post-operation
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(mg/mL)
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3 months post-operation
|
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PSA level in blood
大体时间：6 months post-operation
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(mg/mL)
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6 months post-operation
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PSA level in blood
大体时间：12 months post-operation
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(mg/mL)
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12 months post-operation
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local and regional recurrences on sonography
大体时间：through study completion, an average of 1 year
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including ultrasound when PSA rising or any indication of recurrent
|
through study completion, an average of 1 year
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local and regional recurrences, on MRI
大体时间：through study completion, an average of 1 year
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including MRI when PSA rising or any indication of recurrent
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through study completion, an average of 1 year
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local and regional recurrences, on PET Scan
大体时间：through study completion, an average of 1 year
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including PET Scan, when PSA rising or any indication of recurrent
|
through study completion, an average of 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
大体时间：Preoperative
|
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.
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Preoperative
|
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Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)
大体时间：3 months postoperative
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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.
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3 months postoperative
|
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Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
大体时间：6 months, postoperative
|
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.
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6 months, postoperative
|
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Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
大体时间：12 months postoperative.
|
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.
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12 months postoperative.
|
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Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
大体时间：Preoperative
|
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.
|
Preoperative
|
|
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
大体时间：3 months, postoperative
|
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.
|
3 months, postoperative
|
|
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
大体时间：6 months, postoperative.
|
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.
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6 months, postoperative.
|
|
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
大体时间：12 months postoperative
|
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.
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12 months postoperative
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The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
大体时间：Preoperative
|
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.
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Preoperative
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|
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
大体时间：3 months, postoperative.
|
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.
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3 months, postoperative.
|
|
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
大体时间：6 months, postoperative
|
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.
|
6 months, postoperative
|
|
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
大体时间：12 months postoperative
|
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.
|
12 months postoperative
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Hung V Tran, MD, PhD、Binh Dan Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年1月1日
初级完成 (预期的)
2020年12月31日
研究完成 (预期的)
2020年12月31日
研究注册日期
首次提交
2019年5月13日
首先提交符合 QC 标准的
2019年7月4日
首次发布 (实际的)
2019年7月9日
研究记录更新
最后更新发布 (实际的)
2020年7月14日
上次提交的符合 QC 标准的更新
2020年7月12日
最后验证
2020年7月1日
更多信息
与本研究相关的术语
其他研究编号
- BD022019
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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