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Updated: Oct 16, 2025

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Open vs robot-assisted radical cystectomy (BORARC): a double-blinded, randomised feasibility study.

Sophia L Maibom1,2, Martin A Røder1,2, Eske K Aasvang2,3

  • 1Urological Research Unit, Department of Urology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.

BJU International
|October 17, 2021
PubMed
Summary

Blinding patients and doctors to radical cystectomy (RC) techniques is feasible, though nurses were unblinded. This study supports conducting blinded phase III trials for optimal surgical techniques in RC.

Keywords:
#BladderCancer#blcsm#urooncEnhanced Recovery After Surgerybladder cancerradical cystectomyrandomised controlled trial

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Area of Science:

  • Urology
  • Surgical Oncology
  • Clinical Trials

Background:

  • Radical cystectomy (RC) is a standard treatment for bladder cancer.
  • Assessing surgical techniques requires robust methodology, including blinding.
  • Previous studies on RC techniques have been limited by a lack of blinding.

Purpose of the Study:

  • To evaluate the feasibility of blinding patients and care providers during radical cystectomy (RC).
  • To assess surgical outcomes in a double-blinded comparison of open RC versus robot-assisted RC.

Main Methods:

  • A single-centre, double-blinded, randomised feasibility study comparing open RC (ORC) and robot-assisted RC (iRARC).
  • 50 patients with bladder cancer undergoing RC with ileal conduit were included.
  • Primary outcomes: proportion of unblinded patients and blinding success (Bang's Blinding Index). Secondary outcomes: length of stay, complications, blood loss, pain, opioid use.

Main Results:

  • 26% of patients were unblinded before discharge.
  • Patients and doctors remained blinded; nurses did not.
  • Greater blood loss in ORC; longer operative time in iRARC.
  • No significant differences in complication rates, length of stay, or analgesic use.

Conclusions:

  • Blinding of surgical technique in RC is achievable.
  • Secondary outcomes align with previous unblinded trials.
  • The study demonstrates the possibility of conducting a blinded phase III trial for RC techniques.