Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03049410 |
| Other study ID # |
16/0584 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2017 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
University College, London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a prospective multicentre randomised controlled trial comparing the outcomes from
Intracorporeal RARC (iRARC) with open radical cystectomy (ORC) in patients with bladder
cancer. The study will recruit patients with non-muscle invasive bladder cancer (NMIBC) or
muscle invasive bladder cancer (MIBC) who have selected radical cystectomy for the treatment
of bladder cancer. The time of interest for measurement of the primary outcomes will be 90
days post-surgery.
Eligible patients will include those receiving neo-adjuvant chemotherapy (typically
gemcitabine and cisplatin) and those having either an ileal conduit or a neo-bladder
reconstruction.
Patients who have selected radical cystectomy after appropriate counselling and following a
specialist multi-disciplinary team (SMDT) recommendation, will be approached and asked to
consent for this study.
Consenting participants will be randomised 1:1 to either iRARC or ORC. Patients will be
followed for a minimum of 90 days post-surgery.
The study will be conducted in National Health Service (NHS) Trusts designated as Cancer
Centres.
Patients will be stratified by
- Type of urinary diversion (Continent diversion or ileal conduit)
- Performance status
- Centre Trial assessments will be conducted at baseline (before surgery), whilst
participants are on admission and then 5, 12, 26 weeks,1 year and 18 months post
surgery.
Description:
Radical cystectomy (RC) represents the gold standard treatment for invasive bladder cancer.
Reductions in morbidity and mortality from this operation have occurred in recent years
through refined anaesthesia, surgical techniques, and centralization of services in high
volume centres. The multimodal concept of enhanced recovery after RC (ERAS), which includes
pre, intra and post operative steps, has also helped to reduce the length of stay and
complications after RC further.
For most abdominal surgery, it is recognized that minimally invasive surgery is less morbid
than open surgery, and produces improvements in post-operative recovery without altering the
curative nature of the procedure. However, to date, there is little or conflicting evidence
of any benefit from minimally invasive surgery over open surgery for RC. This may reflect the
complex nature of this procedure (involving surgery to both the urinary and gastro-intestinal
tracts), limitations of the current evidence or that there is no benefit. To date, three
prospective trials have compared RARC with open RC (ORC). However, each has been limited by
sample size and design, or their application of RARC with extra-corporeal reconstruction or
have yet to report.
The investigators believe that there are no studies (reported or planned) that have compared
optimal RARC (e.g. with intra-corporeal reconstruction) with optimal ORC (e.g. high volume
centre using ERAS). In addition, the investigators believe none have adequately assessed the
rehabilitation from RC. As such, the investigators now propose a prospective RCT to randomize
eligible patients to either ORC or RARC. The investigators will focus upon measures of
functional recovery and the return to normal activities.
