Lateral Prostate Capsule Sparing Versus Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male
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 continence rate
研究概览
简要总结
To compare the perioperative, functional, and oncologic outcomes between nerve sparing and lateral prostate capsule sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.
详细描述
This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy with orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to surgical procedures: nerve sparing group and lateral prostate capsule sparing group. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.
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
- Single (Participant)
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 without tumour in the bladder neck or urethra, and prostate cancer was ruled out by MRI and serum T-PSA<2.5ng/ml.
- •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 continence rate
时间窗: 6 months
Patients were considered continent when they required 0 or 1 safety pad during the day time
night-time continence rate
时间窗: 6 months
Patients were considered continent when they required 0 or 1 safety pad during the night.
postoperative sexual function
时间窗: 6 months
The sexual function are evaluated by the international index of erectile function-5 (IIEF-5).
次要结局
- estimated blood loss(24 hours)
- overall survival(1 year)
- recurrence-free survival(1 year)
- perioperative complication rate(3 months)
- operative time(24 hours)