A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.
研究概览
简要总结
The purpose of this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. The removal of the bladder and lymph nodes will be done by a robotic or by an open technique. It may be a Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Scheduled for radical cystectomy at MSKCC
排除标准
- •Prior pelvic or abdominal radiation therapy;
- •Prior extensive open abdominal surgery, defined by the discretion of the attending surgeon
- •Any clinical contraindication for Trendelenburg positioning
研究组 & 干预措施
open radical cystectomy
This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer.
干预措施: open radical cystectomy (Procedure)
robotic-assisted radical cystectomy
This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer.
干预措施: robotic-assisted radical cystectomy (Procedure)
结局指标
主要结局
To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.
时间窗: intraoperative and 90-day postoperative period
次要结局
- To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy.(2 years)
- complications grade 2-5(2 years)
- Intra-operative performance (surgical time, blood loss)(time from anesthesia induction to final skin closure)
- Pathologic findings, including the stage specific, soft tissue surgical margin rate and number of lymph nodes removed.(1.5 years)
- Bladder cancer recurrence (local, upper tract and distant disease)(2 years)
- complication grade 3-5(2 years)