NCT02174185Unknown不适用
A Prospective and Comparative Study of Health-related Quality of Life (HRQoL) in Patients With Conduit Diversion or Orthotopic Neobladder
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions
研究概览
简要总结
The aim of this study is to compare the health-related quality of life (HRQoL) between patients underwent conduit diversion and orthotopic neobladder after radical cystectomy. The investigators plan to use validated HRQoL questionnaires to learn about how the different urinary diversion operations affect the HRQoL of people living with bladder cancer. The findings from this study may help doctors and patients choosing the proper operation type.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of muscle invasive bladder cancer
- •Must be scheduled for radical cystectomy and subsequent conduit diversion or orthotopic neobladder
- •Must be able to provide informed consent
- •Must be 18 years of age or older
- •May have had received intravesical neoadjuvant, adjuvant chemotherapy or immunotherapy
排除标准
- •Follow-up data not obtained at Wuhan Union Hospital
结局指标
主要结局
Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions
时间窗: Preoperative baseline and 3, 6, 12, 18 months postoperatively
次要结局
- Score differences between the two groups of patients in the relevant domains from three various validated tools of HRQoL(Preoperative baseline and 3, 6, 12, 18 months postoperatively)
- Score changes of each patient group during the follow-up(Preoperative baseline and 3, 6, 12, 18 months postoperatively)
- Objective examination outcomes(Preoperative baseline and 3, 6, 12, 18 months postoperatively)
研究者
Zhang Xiaoping
Director of Department of Urology, Wuhan Union Hospital, HUST
Huazhong University of Science and Technology
研究点 (1)
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