NCT04958343Unknown不适用
Application and Clinical Effectiveness of Pelvic Reconstruction in Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder in the Male
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年7月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- day-time and night-time continence rate
研究概览
简要总结
To study the effect of pelvic reconstruction on early return of continence after robot-assisted radical cystectomy-orthotopic ileal neobladder in the male.
详细描述
This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy-orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to whether received pelvic reconstruction or not. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Male patients aged 18 or older.
- •Patients those who are diagnosed with urothelial carcinoma.
- •Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
- •Patients those who are able to cooperate and complete the follow-up.
- •Patients those who volunteer to participate in this study and sign the informed consens.
排除标准
- •Patients thsoe who are diagnosed distant metastasis before surgery.
- •Patients those who are diagnosed with other malignancies.
- •Patients those who had received pelvic radiotherapy or major pelvic operation.
结局指标
主要结局
day-time and night-time continence rate
时间窗: 6 months
Patients were considered continent when they required 0 or 1 safety pad during the day or at night.
次要结局
- operative time(24 hours)
- overall survival(1 year)
- perioperative complication rate(3 months)
- recurrence-free survival(1 year)
- estimated blood loss(24 hours)
研究者
研究点 (1)
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