Neobladder Posterior Wall Suspended With Round Ligament of Uterus After Radical Cystectomy in Female With Bladder Cancer -a Prospective Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- postvoiding residual urine (PVP)
研究概览
简要总结
Objective: to evaluate if the Neobladder posterior wall suspended with round ligament of uterus could improve neobladder empty after radical cystectomy in female patients with bladder cancer compared to present standard neobladder
详细描述
The investigators developed a technical modification which to aim to provide an posterior support to the ideal neobladder and obtain the anatomy recovered neobladder by posterior wall of neobladder suspended with round ligament. In this study the investigators designed the prospective random trial to evaluate whether this technique improves the neobladder empty compared to a current standard neobladder reconstruction.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria for the study were bladder cancer (Stage T1G3, T2-3N0-NxM0), female (age between 40 and 70 years old), no history of urethral trauma or urethral stricture; and a desire to obtain an orthotopic neobladder
排除标准
- •The exclusion criteria were male sex, posterior urethral margin confirmed as cancer invasive by pathology; and enteritis. The indications and contraindications for orthotopic reconstruction in this study conformed to the criteria set by the guidelines of the European Association of Urology on bladder cancer
研究组 & 干预措施
neobladder with round lig
ileal neobladder suspened with round ligament
干预措施: rONB (Procedure)
standard neobladder
conventional standard neobladder
结局指标
主要结局
postvoiding residual urine (PVP)
时间窗: 2 years after operation
number of patients with postvoiding residual urine (PVP) more than 100ml
clean intermittent catheterization(CIC)
时间窗: 2 years after operation
number of patients required clean intermittent catheterization(CIC)
次要结局
- rate of complication(through study completion, an average of 2 years)
- urodynamic profile(12 months afer operation)
- rate of continence of neobladder(12 months after operation)
研究者
Zhiwen Chen
Vice director of urological institiute of PLA
Southwest Hospital, China