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
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
Scientific
Department of Urology
Institute of Clinical Sciences
University of Gothenburg
Bruna stråket 11B
Sahlgrenska University Hospital
Gothenburg
413 45
Sweden
 ORCID ID |
0000-0001-6441-4729 |
|---|---|
| Phone | +46 31 342 10 00 |
| henrik.kjolhede@vgregion.se |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN64538003_PIS_10Oct19.pdf |
| Scientific title | Robotic-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 acronym | RACER |
| Study objectives | Robot 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) studied | Bladder cancer |
| Intervention | For 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 type | Other |
| Primary outcome measure | Progression-free survival at three years following cystectomy |
| Secondary outcome measures | Surgical 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 date | 01/09/2019 |
| Completion date | 01/09/2028 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 488 |
| Key inclusion criteria | 1. 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 criteria | 1. Distant metastasis (M1) 2. Unfit for either type of procedure 3. Extant ileo- or colostomy 4. Duplicated ureters |
| Date of first enrolment | 04/11/2019 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Bruna Stråket 11B
Gothenburg
413 45
Sweden
Jan Waldenströms Gata 5
Malmö
214 28
Sweden
Sponsor information
University/education
413 45 Gothenburg
Gothenburg
413 45
Sweden
| Phone | +46 31 342 10 00 |
|---|---|
| sahlgrenska.universitetssjukhuset@vgregion.se | |
| Website | https://www.sahlgrenska.se/en/ |
"ROR" |
https://ror.org/04vgqjj36 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/06/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The 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
