NCT04696263撤回不适用
Prospective Single-Center Randomized Study Of Single-Port Versus Multi-Port Robotic Radical Prostatectomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Recovery of Urinary Continence Following Catheter Removal
研究概览
简要总结
The purpose of this study is to compare two different techniques to perform the standard of care surgery to treat prostate cancer. This surgery is called robotic radical prostatectomy. There are two robotic surgical systems approved by the Food and Drug Administration (FDA) to perform this surgery. First system is called the Da Vinci ® Xi system. With this system, six small incisions are made during the surgery. Second system is called the Da Vinci ® SP system. With this system a single incision is made during the surgery. Same surgery is done with each surgical system. This study aims to understand whether a single incision surgery ends up with better recovery after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants must have histologically or cytologically confirmed prostate cancer, stage T1a, T2a or T2b prostate cancer using MRI staging.
- •Life expectancy greater than 10 years.
- •Participants must have ability to understand and the willingness to sign a written informed consent document or have a surrogate with the ability to understand and the willingness to sign a written informed consent for radical prostatectomy.
排除标准
- •Participants with any prior extensive pelvic surgery or pelvic fractures.
- •Prior treatment for prostate cancer such as radiotherapy or focal therapy.
- •Uncorrected coagulopathy.
- •Active soft tissue or urinary infection.
- •Poor surgical risk (defined as American Society of Anesthesiology score > 3)
- •Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.)
- •Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
结局指标
主要结局
Recovery of Urinary Continence Following Catheter Removal
时间窗: Up to 12 months post-treatment
Continence will be defined as the absence of pads (even safety pads).
次要结局
- Estimated blood loss in milliliters(During operation, an average operative time is 192 minutes)
- Number of participants requiring Intraoperative Trendelenburg position(Within 24 hours of surgery)
- Number of SP procedures converted to other procedure types(Within 24 hours of surgery)
- Time to solid oral intake(Post-surgery, an average of 16 hours)
- Participant and Observer Scar Assessment Scale scores(Up to 1 year)
- Number of pads used daily(Up to 1 year)
- Operative time(During operation, an average operative time is 192 minutes)
- Number of additional ports(Within 24 hours of surgery)
- Intraoperative complication rate(Within 24 hours of surgery)
- Intraoperative peritoneum breach rate(Within 24 hours of surgery)
- Visual analog pain scale scores(Within 7 days of surgery)
- Units of parenteral morphine equivalents (mg)(Up to 1 month post-procedure)
- International Index of Erectile Function (IIEF-5) scale scores(Up to 1 year)
- Time to return-to-work(Up to 1 year)
- Time to liquid oral intake(Post-surgery, an average of 16 hours)
- Body image questionnaire scores(Up to 1 year)
- Number of postoperative complications(Within 30 days)
- Time to baseline(Up to 1 year)
- Hospital stay in hours(Post-surgery, an average of 16 hours)
研究者
研究点 (2)
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