|- candidate number||22746|
|- NTR Number||NTR5362|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-aug-2015|
|- Secondary IDs||843002602; 2015-1942 ZonMw; CMO regio Arnhem-Nijmegen|
|- Public Title||RAdicale Cystectomy Evaluation. Comparative Effectiveness Study of Open
versus Robot Assisted Laparoscopic Surgery|
|- Scientific Title||RAdicale Cystectomy Evaluation. Comparative Effectiveness Study of Open
versus Robot Assisted Laparoscopic Surgery|
|- hypothesis||Objective: To study the (cost-)effectiveness of robotic compared to open cystectomy in
patients with bladder cancer|
|- Healt Condition(s) or Problem(s) studied||Bladder carinoma, Cystectomy, Complications, Cost-effectiveness |
|- Inclusion criteria||• Patients with non-metastatic muscle-invasive (cT2-T4a) and uncontrolled or highrisk
non Muscle-invasive bladder cancer (pTa-pT1)|
• Age >=18
• Able to fill in questionnaires
• Signed informed consent
|- Exclusion criteria||• Extensive previous abdominal surgery|
• Abdominal irradiation
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-dec-2015|
|- planned closingdate||1-dec-2019|
|- Target number of participants||338|
|- Interventions||Robot assisted radical cystectomy (RARC) will be compared with open radical cystectomy (ORC)|
|- Primary outcome||Complications, i.e. the 90 days overall complication rate according to the Clavien-Dindo classification.|
|- Secondary outcome||HRQOL, time to return to normal activity, operating time, hospital and intensive care stay, blood loss, transfusion parameters, costs, pathology results|
|- Timepoints||Perioperative morbidity and mortality are evaluated using the modified Clavien grading system for complications by prospectively recording intraoperative and postoperative complications until discharge and by patient questionnaires/interviews during the post-discharge period until 90 days after surgery.
HRQL outcomes are measured at baseline and postoperatively at 1,3, 6 and 12 months using the Functional Assessment of Cancer Therapy–Vanderbilt Cystectomy Index (FACT- BI-Cys) , the Bladder Cancer Index (BCI), and the EQ-5D questionnaires.
Pathological data is obtained from pathology reports after surgery with particular emphasis on surgical margin status, total number of lymph nodes removed and their involvement with cancer, as well as pathological stage of the tumour. A standardised form will be used to collect all information pertaining to specimen processing and staging by the participating institutions.|
Perioperative measures, e.g. blood transfusion rates, intraoperative fluid requirements, operative time, postoperative length of hospital stay and analgesic requirement, are prospectively recorded during surgery and the postoperative hospital stay using anaesthesia, operative, nursing and inpatient medical records by a research nurse. Operating time is defined as the skin to skin operating time in minutes not including anaesthetic preparations as these might differ between the participating hospitals.
All patients will be instructed to record their symptoms during the study period. Resource use will be assessed using two questionnaires. The iMCQ will be used to assess medical consumption such as hospital visits, medication use and domestic help. The iPCQ will be used to measure absence from work due to illness. Both questionnaires will be completed at the start of the study before the treatment and every 3 months afterwards. The total follow-up will be 12 months.
|- Trial web site||http://www.racestudie.nl/|
|- CONTACT FOR PUBLIC QUERIES||drs. C.J. Wijburg|
|- CONTACT for SCIENTIFIC QUERIES||drs. C.J. Wijburg|
|- Sponsor/Initiator ||Rijnstate Ziekenhuis|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||OBJECTIVE/RESEARCH QUESTION:
To study the (cost-)effectiveness of robotic compared to open cystectomy in patients with bladder cancer.
An open multi-centre comparative effectiveness study in 338 patients with bladder cancer in 23 centers (11
RARC, 12 ORC) in the Netherlands. Follow-up will be 12 months.
Patients selected for a radical cystectomy according to current guidelines.
December 2015 – December 2019, 48 months
|- Main changes (audit trail)|
|- RECORD||14-aug-2015 - 26-aug-2015|