Trial to Compare Robotically Assisted Radical Cystectomy With Open Radical Cystectomy

Radical cystectomy (RC) represents the gold standard treatment for invasive bladder cancer. Reductions in morbidity and mortality from this operation have occurred in recent years through refined anaesthesia, surgical techniques, and centralization of services in high volume centres. The multimodal concept of enhanced recovery after RC (ERAS), which includes pre, intra and post operative steps, has also helped to reduce the length of stay and complications after RC further.

For most abdominal surgery, it is recognized that minimally invasive surgery is less morbid than open surgery, and produces improvements in post-operative recovery without altering the curative nature of the procedure. However, to date, there is little or conflicting evidence of any benefit from minimally invasive surgery over open surgery for RC. This may reflect the complex nature of this procedure (involving surgery to both the urinary and gastro-intestinal tracts), limitations of the current evidence or that there is no benefit. To date, three prospective trials have compared RARC with open RC (ORC). However, each has been limited by sample size and design, or their application of RARC with extra-corporeal reconstruction or have yet to report.

The investigators believe that there are no studies (reported or planned) that have compared optimal RARC (e.g. with intra-corporeal reconstruction) with optimal ORC (e.g. high volume centre using ERAS). In addition, the investigators believe none have adequately assessed the rehabilitation from RC. As such, the investigators now propose a prospective RCT to randomize eligible patients to either ORC or RARC. The investigators will focus upon measures of functional recovery and the return to normal activities.

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