Urinary Continence of Female Pelvic Organ-preserving Radical Cystectomy and Orthotopic Ileal Neobladder: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 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 compare the urinary continence rate and long-term oncological outcomes of pelvic-organ preserving radical cystectomy (POPRC) with orthotopic ileal neobladder (OIN) versus standard radical cystectomy(SRC) with OIN.
详细描述
Radical cystectomy is the gold standard for muscle-invasive bladder. Orthotopic ileal neobladder, as one of the urinary diversion methods, is preferred whenever possible to achieve a better postoperative quality of life.
For standard radical cystectomy (SRC) in females, the uterus, fallopian tubes, ovaries, anterior vaginal wall, and regional lymph nodes undergo en bloc resection with the bladder and urethra . With regard to the wide range of resection, continence disorder and sexual dysfunction are very common after surgery. Pelvic-organ sparing radical cystectomy involves the preservation of the female vagina, uterus, neurovascular bundles, and any enhancement of the aforementioned techniques . Previous studies demonstrated that POPRC might not affect long-term survival and instead improve continence outcomes. However, most of the available studies are retrospective with limited cases in a single center. The current study primarily aims to urinary continence rate and long-term oncological outcomes of POPRC+OIN versus SRC+OIN in a prospective randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged between 55-
- •Patients those who are diagnosed with organ-confined urothelial carcinoma（<pT3）
- •Patients those who are capable for radical cystectomy with orthotopic ileal neobladder.
- •ECOG score between 0-2;
- •Normal renal function;
- •Patients those who volunteer to participate in this study and sign the informed consents.
- •Patients those who are able to cooperate in the study.
排除标准
- •Absence of tumour in bladder neck or urethra;
- •Patients thsoe who are diagnosed distant metastasis before surgery.
- •Previous history of malignancy of pelvic organs or surgical resection of pelvic organs;
- •Patients those who are diagnosed with other malignancies.;
- •Patients those who had received pelvic radiotherapy or major pelvic operation.
- •Pregnancy status;
- •Any other conditions that the researcher considers to be excluded from this study
结局指标
主要结局
day-time and night-time continence rate
时间窗: 6 months
We will use pad-test to evaluate the urinary continence for patients
次要结局
- postoperative sexual function(6 months)
- perioperative complications rate(1 months)
- overall survival(5 years)
- recurrence-free survival(5 years)
- operative time(24 hours)
- estimated blood loss(24 hours)