Trial to Compare Robotically Assisted Radical Cystectomy With Open Radical Cystectomy (iROC)

May 7, 2026 updated by: University College, London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

339

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom
        • North Bristol NHS Trust
      • Glasgow, United Kingdom
        • Queen Elizabeth University Hospital
      • Leeds, United Kingdom
        • St James' University Hospital
      • London, United Kingdom, NW1 2BU
        • University College London Hospitals NHS Foundation Trust
      • London, United Kingdom
        • Guy's Hospital
      • Reading, United Kingdom
        • Royal Berkshire Hospital
      • Sheffield, United Kingdom, S10 2JF
        • Sheffield Teaching Hospitals NHS Foundation Trust
      • Stevenage, United Kingdom
        • Lister Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: iRARC
Intracorporeal Robot Assisted Radical Cystectomy
Procedure: Intracorporeal Robot Assisted Radical Cystectomy
Intracorporeal robot assisted radical cystoprostatectomy or anterior exenteration
Active Comparator: Open Radical Cystectomy (ORC)
Open Radical Cystectomy
Procedure: Open Radical Cystectomy
Removal of bladder and adjacent organs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days at home within 90 days of the surgery
Time Frame: 90 days post surgery
To compare the number of days alive and out of hospital within 90 days from surgery.
90 days post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difficulties due to health conditions measured using WHODAS version 2.0
Time Frame: 12 months post surgery
To assess recovery and complications and the return to normal activities.
12 months post surgery
Quality of Life measured using EQ-5D-5L Health Questionnaire and EORTC QLQ-C30 version 3.
Time Frame: 12 months post surgery
To assess recovery and complications and the return to normal activities.
12 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: John Kelly, University College, London
  • Principal Investigator: James Catto, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

February 2, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Actual)

February 10, 2017

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/0584

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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