A Randomized Comparison of the Studer Pouch vs. the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 529
- 试验地点
- 1
- 主要终点
- The primary endpoint is the long-term outcome (> 3 years) as it pertains to renal function, anatomy of the upper urinary tracts, and the requirement for medical or surgical intervention (ie for symptomatic urinary tract infections).
研究概览
简要总结
This is a prospective, randomized study of two types of continent ileal neobladder construction in patients undergoing cystectomy for primary bladder cancer. Patients will be randomly assigned to have either a T-pouch or a Studer pouch constructed at the time of their surgery. They will be followed long-term to determine the relative advantages and disadvantages of the two types of diversion. The investigators' hypothesis is that the inclusion of an antireflux mechanism in the T-pouch will result in significantly fewer episodes of symptomatic urinary tract infection, and will have a lower incidence of upper tract dilation and loss of renal function over the long term.
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
- None
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
- •All patients undergoing radical cystectomy for bladder cancer who are considered candidates for a neobladder reconstruction are eligible for enrollment.
- •Diagnosed with primary bladder cancer (any histology).
- •Scheduled to undergo a radical cystectomy (cystoprostatectomy in men and anterior exenteration in women).
- •Felt by the treating physician to be a candidate for an orthotopic neobladder urinary diversion.
- •Be competent and willing to sign the informed consent.
- •Patients may have received previous radiation therapy or intravesical or systemic chemotherapy. Patients with documented metastatic disease are not excluded as long as they are felt to be candidates for a continent neobladder urinary diversion.
排除标准
- •Patients undergoing radical cystectomy for any malignancy other than primary bladder cancer (for example prostate cancer or colon cancer invading the bladder,or a gynecologic malignancy), or non-malignant disease (such as a neurogenic bladder or radiation cystitis).
- •Unwilling or unable to sign the informed consent.
- •Not eligible for an orthotopic neobladder reconstruction.
- •A history of other malignancy (except for stage I cancer treated with curative intent without evidence of recurrence, clinically localized prostate cancer either untreated or treated with prostatectomy or radiation therapy or hormone therapy,or non-melanoma skin cancer) within the previous 5 years.
研究组 & 干预措施
Studer Pouch
Studer Pouch orthotopic urinary diversion
干预措施: Studer Pouch orthotopic urinary diversion (Procedure)
T-Pouch
T-Pouch orthotopic urinary diversion
干预措施: T-Pouch orthotopic urinary diversion (Procedure)
结局指标
主要结局
The primary endpoint is the long-term outcome (> 3 years) as it pertains to renal function, anatomy of the upper urinary tracts, and the requirement for medical or surgical intervention (ie for symptomatic urinary tract infections).
时间窗: 3 years after date of last patient enrolled
次要结局
- A secondary endpoint is the length of surgery and the incidence of early postoperative complications (<30 days from surgery) believed to be related to the type of urinary diversion.(Within 30 days after surgery)
- An additional secondary endpoint is cancer recurrence and overall survival, which will be recorded in each patient.(Yearly for the first 5 years, then every 2 years)