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Trial to Compare Robotically Assisted Radical Cystectomy With Open Radical Cystectomy

NCT03049410 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2026-05-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Intracorporeal Robot Assisted Radical Cystectomy

Intracorporeal robot assisted radical cystoprostatectomy or anterior exenteration

PROCEDURE

Open Radical Cystectomy

Removal of bladder and adjacent organs

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • John Kelly · University College, London

  • James Catto · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03049410 on ClinicalTrials.gov