Trial to Compare Robotically Assisted Radical Cystectomy With Open Radical Cystectomy

This is a prospective multicentre randomised controlled trial comparing the outcomes from Intracorporeal RARC (iRARC) with open radical cystectomy (ORC) in patients with bladder cancer. The study will recruit patients with non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancer (MIBC) who have selected radical cystectomy for the treatment of bladder cancer. The time of interest for measurement of the primary outcomes will be 90 days post-surgery. Eligible patients will include those receiving neo-adjuvant chemotherapy (typically gemcitabine and cisplatin) and those having either an ileal conduit or a neo-bladder reconstruction. Patients who have selected radical cystectomy after appropriate counselling and following a specialist multi-disciplinary team (SMDT) recommendation, will be approached and asked to consent for this study. Consenting participants will be randomised 1:1 to either iRARC or ORC. Patients will be followed for a minimum of 90 days post-surgery. The study will be conducted in National Health Service (NHS) Trusts designated as Cancer Centres. Patients will be stratified by * Type of urinary diversion (Continent diversion or ileal conduit) * Performance status * Centre Trial assessments will be conducted at baseline (before surgery), whilst participants are on admission and then 5, 12, 26 weeks,1 year and 18 months post surgery.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Participants must be over 18 years of age.
* Male or female
* Histopathological confirmation of bladder cancer (UCC, SCC, adenocarcinoma or rare variant)
* CIS or stage pTa or pT1 or ≥pT2 or mobile bladder mass on bimanual examination under anaesthesia (see Section 22: Definitions for TNM definitions)
* Node status ≤ N1 on imaging criteria or PET -ve outside pelvis
* ECOG grade 0, 1, 2 or 3
* Able to give informed written consent to participate.

Exclusion Criteria:

* Unwilling to undergo cystectomy.
* Previous abdominal surgery rendering them unsuitable for either iRARC or ORC.
* Patients with upper urinary tract disease
* Concomitant disease that would render the patient unsuitable for the trial
* Pregnant or lactating females
* Previous radiotherapy for bladder cancer

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