Prospective Randomized Comparison of Robotic Versus Open Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in patient reported quality of life, as measured by the EORTC-QLQ-C30
研究概览
简要总结
This randomized phase II trial studies how well robotic radical cystectomy (RRC) or open radical cystectomy (ORC) works in treating patients with bladder cancer. Cystectomy is a surgical procedure to remove all or part of the bladder (the organ that holds urine) or to remove a cyst (a sac or capsule in the body). In RRC, the the surgeon makes small cuts in the abdomen and uses a thin, lighted instrument with a camera attached called a scope. With the help of a robot, the surgeon removes the bladder and other nearby structures. In ORC, the surgeon makes a cut into the lower abdomen to expose the urinary tract in order to remove the bladder and nearby structures. It is not yet known whether RRC or ORC has fewer complications, better quality of life, and faster recovery time in treating patients with bladder cancer.
详细描述
PRIMARY OBJECTIVES:
I. To compare RRC to ORC in terms of the difference in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core (QLQC)30 quality of life instrument assessed at baseline to day 30 after radical cystectomy (RC).
II. To compare RRC to ORC in terms of the 90-day high-grade complication rate (where high grade is defined as Clavien-Dindo grade 3-5).
III. To compare the peri-operative cost of the RC procedure, as defined as from the day of hospital admission to the day of hospital discharge.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for radical cystectomy for urothelial cancer
- •All types of urinary diversions
- •Tis-T3 Urothelial cancer; patients will be stratified according to clinical stage
- •Ability to consent
- •Patient meets criteria to be a surgical candidate
排除标准
- •Inability to give consent or adhere to follow-up schedule
- •Bulky lymphadenopathy (> 2 cm)
- •Prior pelvic radiation
- •Not surgical candidate because of significant co-morbidity
- •Uncontrolled coagulopathy
研究组 & 干预措施
Arm I (RRC)
Patients undergo RRC at day 0.
干预措施: Questionnaire Administration (Other)
Arm I (RRC)
Patients undergo RRC at day 0.
干预措施: Radical Cystectomy (Procedure)
Arm II (ORC)
Patients undergo ORC at day 0.
干预措施: Questionnaire Administration (Other)
Arm II (ORC)
Patients undergo ORC at day 0.
干预措施: Radical Cystectomy (Procedure)
结局指标
主要结局
Change in patient reported quality of life, as measured by the EORTC-QLQ-C30
时间窗: Baseline and 1-month post cystectomy
The results for the two arms will be summarized using graphical methods and standard descriptive statistics. Means (or medians) and associated 95% confidence intervals-for each arm separately and for the difference-will be used to display the patterns. For QoL variables that are assessed at multiple times post cystectomy, regression methods that accommodate repeated measures will be used to assess patterns over time. Analyses will compare the two arms using general linear regression models and stratifying for the four variables used for stratification prior to randomization.
次要结局
- Change in erectile dysfunction, as measured by the SHIM score(up to 12 months)