Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Perioperative transfusion rate (%)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •The patient lacks the ability to consent for themselves;
- •Patients unwilling to undergo pre- and post-operative evaluation according to the protocol;
结局指标
主要结局
Perioperative transfusion rate (%)
时间窗: Up to 1 month after operation
The number of cases which will be transfused.
The console time
时间窗: During the surgery
The time which surgeon spends on the robot console by minuite
The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),
时间窗: 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.
The rate of postoperative complications (including infections)
时间窗: in day 3, day 7, and 1 month after surgery.
Percentage
PSA level in blood
时间窗: 12 months post-operation
(mg/mL)
To assess postoperative hospital stay
时间窗: Up to 1 month after surgery
(day)
Mean of blood loss
时间窗: During the surgery
Milliliter
the rate of conversion to open surgery, the rate of intraoperative incidents (%),
时间窗: Up to 1 weeks after the surgery.
Percentage
The drainage time
时间窗: Up to 3 months after surgery
(day),
To assess urethral catheter time, urethral catheter time
时间窗: Up to 3 months after surgery
(day)
The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,
时间窗: Up to 1 week after operation
Number of cases, based on the result of pathology.
To assess bowel movement recovery time,
时间窗: Up to 1 week after surgery
(day)
local and regional recurrences on sonography
时间窗: through study completion, an average of 1 year
including ultrasound when PSA rising or any indication of recurrent
local and regional recurrences, on MRI
时间窗: through study completion, an average of 1 year
including MRI when PSA rising or any indication of recurrent
local and regional recurrences, on PET Scan
时间窗: through study completion, an average of 1 year
including PET Scan, when PSA rising or any indication of recurrent
Number of blood units transfused
时间窗: Up to 1 week after operation
Milliliter
Change of hemoglobin from baseline
时间窗: Up to 1 week after operation
(mg/mL)
次要结局
- Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)(12 months postoperative.)
- The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire(12 months postoperative)
- Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)(3 months postoperative)
- Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score(12 months postoperative)