iROC

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  211187

• Contact name

  James Catto

• Contact email

  j.catto@sheffield.ac.uk

• Sponsor organisation

  Universit College London

• Clinicaltrials.gov Identifier

  UCL data protection registration number, Z6364106/2016/10/09

• Duration of Study in the UK

  2 years, 11 months, 31 days

• Research summary

  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.

  We 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, we believe none have adequately assessed the rehabilitation from RC. As such, we now propose a prospective RCT to randomize eligible patients to either ORC or RARC. We will focus upon measures of functional recovery and the return to normal activities.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  16/NE/0418

• Date of REC Opinion

  18 Jan 2017

• REC opinion

  Further Information Favourable Opinion