Robotic-assisted versus open removal of the bladder in bladder cancer patients

ISRCTN ISRCTN64538003
DOI https://doi.org/10.1186/ISRCTN64538003
Secondary identifying numbers 2019-00717 / 844-18
Submission date
01/10/2019
Registration date
04/11/2019
Last edited
17/12/2024
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Bladder cancer is one of the most common forms of cancer. For most patients, the bladder cancer is superficial and can be treated locally in the bladder. However, for about one in five patients, cancer invades the bladder muscle and for these the most common curative treatment is cystectomy. Cystectomy can be performed either as open surgery, with a longer incision in the lower abdomen, or as a robot-assisted laparoscopic procedure. Robot-assisted laparoscopic cystectomy has been developed during the last 15 years and is routinely performed at some centres around the world. However, it is not entirely certain that a laparoscopic cystectomy is as safe as open surgery, or that there are sufficient advantages to offset the higher procedure-related costs. The aim of this study is, therefore, to find out whether robot-assisted laparoscopic cystectomy is oncologically as safe as open cystectomy, whether there is a difference in rates of complications, and if it is cost-effective

Who can participate?
Men and women with urinary bladder cancer planned to undergo cystectomy

What does the study involve?
Participants are randomly allocated to either robot-assisted laparoscopic cystectomy (experimental group) or open cystectomy (control group)

What are the possible benefits and risks of participating?
Robot-assisted laparoscopic cystectomy may lead to less blood loss, faster recovery, and fewer complications than open cystectomy. It is possible, however, that there may be an increased risk of recurrence or progression from bladder cancer

Where is the study run from?
University of Gothenburg/Sahlgrenska University Hospital (Sweden)

When is the study starting and how long is it expected to run for?
September 2019 to September 2028

Who is funding the study?
The study is funded by the Agreement concerning research and education of doctors in Sweden

Who is the main contact?
Dr Henrik Kjölhede
henrik.kjolhede@vgregion.se

Contact information

Dr Henrik Kjölhede
Scientific

Department of Urology
Institute of Clinical Sciences
University of Gothenburg
Bruna stråket 11B
Sahlgrenska University Hospital
Gothenburg
413 45
Sweden

ORCiD logoORCID ID 0000-0001-6441-4729
Phone +46 31 342 10 00
Email henrik.kjolhede@vgregion.se

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet ISRCTN64538003_PIS_10Oct19.pdf
Scientific titleRobotic-Assisted radical Cystectomy vErsus open Radical cystectomy: a randomised non-inferiority trial comparing 3-year recurrence-free survival in patients undergoing cystectomy for urothelial carcinoma of the bladder
Study acronymRACER
Study objectivesRobot assisted laparoscopic cystectomy is non-inferior to open cystectomy with regards to 3-year progression-free survival
Ethics approval(s)Approved 07/01/2019, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden; +46-10-4750800), ref: 2019-00717 / 844-18
Health condition(s) or problem(s) studiedBladder cancer
InterventionFor both the treatment arms, eligible patients will be offered neo-adjuvant or induction chemotherapy. Randomisation to robot assisted or open surgery will be performed after any preoperative chemotherapy has been finished. Randomisation will be performed through an electronic data capture system, with a computer-generated list. Treatment arms will be stratified by participating centre and muscle-invasive or non-muscle-invasive disease. Both arms will undergo surgery with an identical enhanced recovery protocol.

Participating subjects will receive either robot assisted laparoscopic cystectomy (experimental arm) or open cystectomy (control arm). The urinary deviation can be performed either entirely intra-corporeally or through a small incision extra-corporeally. The type of deviation is at the discretion of the surgeon and patient. All surgeons participating in the study is mandated to have performed at least 10 cystectomies of the relevant type (open or robotic) in the preceding year.

Follow-up will be performed with CT thorax and abdomen, which will be assessed by RECIST criteria, according to the Swedish National Guidelines for urothelial cancer. This follow-up scheme is dependent on the final pathology report, and may be subject to change according to updates in the National Guidelines.
Intervention typeOther
Primary outcome measureProgression-free survival at three years following cystectomy
Secondary outcome measuresSurgical outcomes:
1. Rate of complications
2. Blood loss
3. Rate of transfusion
4. Time of stay
Long-term outcomes:
5. Rate of unplanned readmission
6. Quality of life measured by questionnaires FACT-G/Bl-Cys and WHODAS2.0 at baseline, and 3, 6 and 12 months and EQ-5D-5L at baseline and weekly for the first 4 postoperative weeks
7. Total health-care related costs following cystectomy, calculated for the direct and indirect costs related to the surgery for the first 6 months
Overall study start date01/09/2019
Completion date01/09/2028

Eligibility

Participant type(s)All
Age groupAdult
SexBoth
Target number of participants488
Key inclusion criteria1. Histologically verified urothelial cancer
2. cT1-4a or BCG-unresponsive CIS
3. N0-1, or N2-3 if response on pre-operative chemotherapy to N0-1
4. Able to sign informed consent
Key exclusion criteria1. Distant metastasis (M1)
2. Unfit for either type of procedure
3. Extant ileo- or colostomy
4. Duplicated ureters
Date of first enrolment04/11/2019
Date of final enrolment31/12/2025

Locations

Countries of recruitment

  • Sweden

Study participating centres

University of Gothenburg/Sahlgrenska University Hospital
Department of Urology
Bruna Stråket 11B
Gothenburg
413 45
Sweden
University of Lund/Skåne University Hospital
Department of Urology
Jan Waldenströms Gata 5
Malmö
214 28
Sweden

Sponsor information

Sahlgrenska University Hospital
University/education

413 45 Gothenburg
Gothenburg
413 45
Sweden

Phone +46 31 342 10 00
Email sahlgrenska.universitetssjukhuset@vgregion.se
Website https://www.sahlgrenska.se/en/
ROR logo "ROR" https://ror.org/04vgqjj36

Funders

Funder type

Government

The study is funded by the Agreement concerning research and education of doctors in Sweden.

No information available

Results and Publications

Intention to publish date01/06/2029
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available as ethical approval does not allow it.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 10/10/2019 04/11/2019 No Yes

Additional files

ISRCTN64538003_PIS_10Oct19.pdf
uploaded 04/11/2019

Editorial Notes

17/12/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2024 to 31/12/2025.
2. The overall end date was changed from 01/09/2027 to 01/09/2028.
3. The intention to publish date was changed from 01/06/2026 to 01/06/2029.
4. The plain English summary was updated to reflect these changes.
04/11/2019: The participant information sheet has been uploaded as an additional file.
10/10/2019: Trial’s existence confirmed by Swedish Ethical Review Authority