ISRCTN13680280
Completed
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 sites338 target enrollmentApril 25, 2017
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- niversity College London
- Enrollment
- 338
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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