Standard open radical cystectomy (ORC) versus robotically assisted radical cystectomy (RARC)

ISRCTN	ISRCTN13680280
DOI	https://doi.org/10.1186/ISRCTN13680280
ClinicalTrials.gov (NCT)	NCT03049410
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	33071
Sponsor	University College London
Funder	The Urology Foundation

Submission date: 19/04/2017
Registration date: 25/04/2017
Last edited: 02/08/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-of-robotic-assisted-keyhole-surgery-for-bladder-cancer-iroc

Contact information

Ms Samim Patel
Public

Surgical & Interventional Trials Unit (SITU)
Division of Surgery & Interventional Science
Faculty of Medical Sciences
University College London
132 Hampstead Road
London
NW1 2BX
United Kingdom

Phone	+44 20 7679 9280
Email	situ.iroc@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment, Surgery
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific 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
Study acronym	iROC
Study objectives	The aim of this study is to compare robotic assisted radical cystectomy versus standard open radical cystectomy to see if one gives better recovery times and less complications than the other.
Ethics approval(s)	NRES Committee North East – Newcastle & North Tyneside 1, 18/01/2017, ref: 16/NE/0418
Health condition(s) or problem(s) studied	Bladder cancer
Intervention	Participants are randomised in a 1:1 ratio to one of two groups. Arm A: Participants undergo a robotically assisted radical cystectomy (RARC). Arm B: Participants undergo a open radical cystectomy (ORC). Patients in both groups will be followed up at 5 weeks, 12 weeks, 24 weeks and 1 year post surgery.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Number of days alive and out of hospital within 90 days from surgery is assessed by reviewing patient’s medical notes and conducting follow-up visits at 5 weeks and 12 weeks after surgery.
Key secondary outcome measure(s)	1. Self-administered WHODAS-2 (12 point) questionnaire at baseline (pre-operative), 5 weeks, 12 weeks, 24 weeks and 1 year after surgery 2. Self-administered EORTC QLQ-BLM30 questionnaire at baseline (pre-operative), 5 weeks, 12 weeks, 24 weeks and 1 year after surgery 3. Self-administered EQ-5D-5L questionnaire at baseline, 5 weeks, 12 weeks, 24 weeks and 1 year after surgery 4. Quantified activity levels: Total steps taken over 7 consecutive days (measured using a wearable tracking device e.g. Fitbit) at baseline (pre-operative), 5 days post-op, 5 weeks, 12 weeks, 24 weeks and 1 year after surgery 5. 30 Second Chair to Stand test: Number of times the patient can stand from sitting in a 30 second interval. This will be conducted in clinic at baseline (pre-operative), 5 weeks, 12 weeks, 24 weeks and 1 year after surgery The following tools will be used to measure complications: Adverse events recorded using the Clavien-Dindo classification.
Completion date	30/09/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	320
Total final enrolment	338
Key inclusion criteria	Current inclusion criteria as of 04/07/2017: 1. Participants must be over 18 years of age 2. Male or female 3. Histopathological confirmation of bladder cancer (UCC, SCC, adenocarcinoma or rare variant) 4. CIS or stage pTa or pT1 or ≥pT2 or mobile bladder mass on bimanual examination under anaesthesia 5. Node status ≤ N1 on imaging criteria or PET –ve outside pelvis 6. ECOG grade 0, 1, 2 or 3 7. Able to give informed written consent to participate Previous inclusion criteria: 1. Participants must be over 18 years of age 2. Male or female 3. Histopathological confirmation of bladder cancer (UCC, SCC, adenocarcinoma or rare variant) 4. CIS or stage pTa or pT1 or ≥pT2 or mobile bladder mass on bimanual examination under anaesthesia 5. Node status ≤ N1 on imaging criteria or PET –ve outside pelvis 6. ASA grade 1,2,3 or 4 7. Able to give informed written consent to participate
Key exclusion criteria	Current exclusion criteria as of 04/07/2017: 1. Unwilling to undergo cystectomy 2. Previous abdominal surgery rendering them unsuitable for either iRARC or ORC 3. Patients with upper urinary tract disease 4. Concomitant disease that would render the patient unsuitable for the trial 5. Pregnant or lactating females 6. Previous radiotherapy for bladder cancer Previous exclusion criteria: 1. Unwilling to undergo cystectomy 2. Previous abdominal surgery other than hernia repair or cholecystectomy 3. Patients with upper urinary tract disease 4. Concomitant disease that would render the patient unsuitable for the trial 5. Pregnant or lactating females
Date of first enrolment	01/03/2017
Date of final enrolment	31/03/2020

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

University College Hospital

235 Euston Road
London
NW1 2BU
United Kingdom

Royal Hallamshire Hospital

Glossop Road
Sheffield
S10 2JF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from situ.iroc@ucl.ac.uk

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		15/05/2022	16/05/2022	Yes	No
Protocol article	protocol	08/08/2018	23/10/2019	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			02/08/2024	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

02/08/2024: Added CRUK link to plain English results.
16/05/2022: Publication reference added.
09/09/2021: The following changes have been made:
1. The ClinicalTrials.gov number has been added.
2. The trial website has been added.
3. The total final enrolment number has been added.
10/12/2019: The following changes have been made:
1. The recruitment end date has been changed from 30/11/2019 to 31/03/2020.
2. The overall trial end date has been changed from 30/11/2020 to 30/09/2021.
3. The intention to publish date has been changed from 30/11/2021 to 30/09/2022.
23/10/2019: Publication reference added.
26/03/2019: The condition has been changed from "Specialty: Cancer, Primary sub-specialty: Bladder Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of urinary tract" to "Bladder cancer" following a request from the NIHR.
01/03/2019: Internal review.
16/01/2018: Cancer Help UK lay summary link added to plain English summary field.
08/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.16/10/2017: Internal review.
15/09/2017: Internal review.
04/07/2017: The Royal Hallamshire Hospital has been added as a trial participating centre. The inclusion and exclusion criteria has been updated.
06/06/2017: Internal review.