ACTRN12622000614796招募中未知
DIVERT: Randomised study assessing the effect of intracorporeal versus extracorporeal urinary diversion on hospital length of stay in patients undergoing robotic assisted cystectomy
Department of Urology Royal Prince Alfred Hospital (RPAH)0 个研究点目标入组 72 人开始时间: 2022年4月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years(—)
- 性别
- All
入选标准
- •To be eligible to enter the study all patients must satisfy the following criteria:
- •1. Adult aged 18 to 80 years of age
- •2. Undergoing Robot-Assisted Radical Cystectomy (RARC) for bladder cancer (and requiring either ileal conduit or neobladder) or RARC for non-functioning lower urinary tract requiring urinary diversion
- •3. Oncologically suitable for robotic cystectomy ie localised bladder cancer
- •Non-invasive disease - Certain high risk high grade NMIBC T1 disease
- •MIBC T2-T4N1M0
- •4. Clinically suitable for robotic cystectomy ie deemed surgical fit for a major operation as deemed by anaesthetic pre-operative assessment
- •5. Cognitively able to give written informed consent for participation
- •6. Elective procedure
- •7. Salvage cystectomy cases will be included where primary treatment with radiation has failed and the patient is oncologically and clinically suitable for robotic cystectomy.
- •8. Concomitant urethrectomy patients will be included
排除标准
- •Patients will be excluded if they present the following exclusion criteria:
- •1. The patient lacks the ability to consent for themselves
- •2. Patient or tumour factors precluding robotic surgery (including not medically fit for surgery, extensive previous abdominal surgery, metastatic disease or potentially unresectable locally advanced disease)
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