ISRCTN13680280已完成未知
A phase III multicentre randomised controlled trial to compare the efficacy of Robotically Assisted Radical Cystectomy (RARC) and intracorporeal urinary diversion with Open Radical Cystectomy (ORC) in patients with bladder cancer
niversity College London0 个研究点目标入组 338 人开始时间: 2017年4月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 338
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30093510 protocol (added 23/10/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35569079/ (added 16/05/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 04/07/2017:
- •1. Participants must be over 18 years of age
- •2. Male or female
- •3. Histopathological confirmation of bladder cancer (UCC, SCC, adenocarcinoma or rare variant)
- •4. CIS or stage pTa or pT1 or =pT2 or mobile bladder mass on bimanual examination under anaesthesia
- •5. Node status = N1 on imaging criteria or PET –ve outside pelvis
- •6. ECOG grade 0, 1, 2 or 3
- •7. Able to give informed written consent to participate
- •Previous inclusion criteria:
- •1. Participants must be over 18 years of age
- •2. Male or female
- •3. Histopathological confirmation of bladder cancer (UCC, SCC, adenocarcinoma or rare variant)
- •4. CIS or stage pTa or pT1 or =pT2 or mobile bladder mass on bimanual examination under anaesthesia
- •5. Node status = N1 on imaging criteria or PET –ve outside pelvis
- •6. ASA grade 1,2,3 or 4
- •7. Able to give informed written consent to participate
排除标准
- •Current exclusion criteria as of 04/07/2017:
- •1. Unwilling to undergo cystectomy
- •2. Previous abdominal surgery rendering them unsuitable for either iRARC or ORC
- •3. Patients with upper urinary tract disease
- •4. Concomitant disease that would render the patient unsuitable for the trial
- •5. Pregnant or lactating females
- •6. Previous radiotherapy for bladder cancer
- •Previous exclusion criteria:
- •1. Unwilling to undergo cystectomy
- •2. Previous abdominal surgery other than hernia repair or cholecystectomy
- •3. Patients with upper urinary tract disease
- •4. Concomitant disease that would render the patient unsuitable for the trial
- •5. Pregnant or lactating females
研究者
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