Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion. Single Centre Prospective Randomized Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Number of participants requiring perioperative transfusions.
Study Overview
Brief Summary
This prospective randomized study is designed to provide high level of evidence supporting superiority of robot assisted (RA) versus open (O) radical cystectomy (RC). The primary endpoint is a 50% reduction of transfusion rate, several perioperative outcomes potentially linked to a reduced invasiveness are considered as secondary endpoints. Investigators hypothesis is that the reduced invasiveness of RARC might turn into a higher adherence to enhanced recovery after surgery (ERAS) protocols (early bowel recovery, reduced need for painkillers and insertion of nasogastric tube) and consequently to shorter hospital stay and to faster return to daily activities. These data will be taken into account in a matched cost analysis between arms. Secondary aims include a between arm matched comparison of perioperative complications, oncologic outcomes (2-yr disease free survival is an accepted surrogate of long term oncologic effectiveness of RC) and functional outcomes (daytime and nighttime continence).
Detailed Description
Despite encouraging data deriving from colorectal surgery, evidences in favor to ERAS protocols following RARC are poor. Moreover, according to a recent survey of surgeons with a specialist interest in RC, the adherence to ERAS protocols is <20% [1].
Retrospective and preliminary data from the robotic consortium have supported oncologic effectiveness of RARC; however in the only prospective randomized trial comparing RARC and ORC urinary diversions were performed extracorporeally, potentially impairing the benefits of minimally invasive surgery [2].
Robot assisted radical cystectomy (RARC) has the aim of providing adequate cancer control while minimizing invasiveness of open radical cystectomy (ORC). The primary end-point of this trial is to demonstrate a reduction of perioperative transfusion rate in RARC arm by 50% compared to ORC arm.
ERAS protocols may significantly contribute to shortening length of hospital stay, a key outcome in this clinical setting of patients receiving RC, being the mean length of hospital stay around 14 days in Italy. Investigators' hypothesis is that the reduced invasiveness of RARC might contribute to an increased adoption of ERAS protocols (reduced need for reinsertion of nasogastric tube, shorter time to first flatus, to mobilization, to regular diet and finally shorter duration of hospital stay).
Assessment of oncologic outcomes of RARC, although not the primary endpoint of the present study, is certainly an outcome of interest. The expected duration of enrollment (18 mo) should provide 2-yr oncologic outcomes for about 66% of patients. Two-year recurrence free survival has been reported as a valid surrogate marker of long term oncologic survival after RC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with muscle invasive high grade urothelial carcinoma (and variant histologies) of the bladder or high grade non muscle invasive BCG recurrent/refractory disease.
Exclusion Criteria
- •Cystectomy without curative intent (palliative, salvage).
- •Patients unfit for robotic cystectomy.
Arms & Interventions
Open Radical Cystectomy
Open Radical Cystectomy, pelvic lymph node dissection, urinary diversion (neobladder or ileal conduit)
Intervention: Open or robotic radical cystectomy (Procedure)
Robot assisted radical cystectomy
Robot assisted radical cystectomy, pelvic lymph node dissection, intracorporeal urinary diversion (neobladder or ileal conduit)
Intervention: Open or robotic radical cystectomy (Procedure)
Outcomes
Primary Outcomes
Number of participants requiring perioperative transfusions.
Time Frame: 30 days
50% reduction of perioperative transfusion rates in robotic arm.
Secondary Outcomes
- Cost analysis.(30 days)
- Number of participants requiring insertion of nasogastric tube(30 days)
- Incidence of Clavien grade 1-2 perioperative complications at 180-d evaluation.(180 days)
- Incidence of Clavien grade 1-2 perioperative complications at 90-d evaluation.(90 days)
- Incidence of Clavien grade 1-2 perioperative complications at 30-d evaluation.(30 days)
- Incidence of patients requiring readmission.(90 days)
Investigators
Giuseppe SImone
MD, PhD, COnsultant Urologist
Regina Elena Cancer Institute