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

ISRCTN	ISRCTN13680280
DOI	https://doi.org/10.1186/ISRCTN13680280
ClinicalTrials.gov number	NCT03049410
Secondary identifying numbers	33071

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

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

Study website

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

Study design	Randomised; Interventional; Design type: Treatment, Surgery
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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 hypothesis	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
Condition	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	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.
Secondary outcome measures	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.
Overall study start date	18/10/2016
Overall study end date	30/09/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 320; UK Sample Size: 320
Total final enrolment	338
Participant 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
Participant 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
Recruitment start date	01/03/2017
Recruitment end date	31/03/2020

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

University College Hospital

235 Euston Road
London
NW1 2BU
United Kingdom

Royal Hallamshire Hospital

Glossop Road
Sheffield
S10 2JF
United Kingdom

Sponsor information

University College London
University/education

Joint Research Office
1st Floor, Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom

Phone	+44 20 3447 5199
Email	randd@uclh.nhs.uk
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Charity

The Urology Foundation

No information available

Results and Publications

Intention to publish date	30/09/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in peer reviewed scientific journals and dissemination of the results at conference presentations and appropriate websites.
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?
Protocol article	protocol	08/08/2018	23/10/2019	Yes	No
Results article		15/05/2022	16/05/2022	Yes	No
HRA research summary			28/06/2023	No	No
Plain English results			02/08/2024	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.