Clinical trial NCT03434132: Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion.
Official title: Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion. Single Centre Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Open Radical Cystectomy
Robotic Radical cystectomy
Intracorporeal urinary diversion
Prospective randdomized trial
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Ministero della Salute, Italy
First posted: 2018-02-15
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Specific Aim 1:To demonstrate superiority of RARC versus ORC in terms of 50% reduction of perioperative transfusion rates.

Specific Aim 2:

To evaluate invasiveness of both surgical approaches by assessing the adherence to ERAS protocols in both and the incidence of perioperative and 30-d, 90d, 180d complications, readmission rates (30d, 90d). Cost analysis will assess the potential impact of shorter hospital stay on overall costs of robotic procedures.

Specific Aim 3:

To assess quality of life at 6-mo, 12-mo and 24-mo follow-up evaluation and to perform a matched comparison of oncologic and functional outcomes between two arms.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants requiring perioperative transfusions.
timeFrame: 30 days
Secondary outcomes:
measure: Number of participants requiring insertion of nasogastric tube
timeFrame: 30 days
measure: Incidence of Clavien grade 1-2 perioperative complications at 30-d evaluation.
timeFrame: 30 days
measure: Incidence of Clavien grade 1-2 perioperative complications at 90-d evaluation.
timeFrame: 90 days
measure: Incidence of Clavien grade 1-2 perioperative complications at 180-d evaluation.
timeFrame: 180 days
measure: Incidence of patients requiring readmission.
timeFrame: 90 days
measure: Cost analysis.
timeFrame: 30 days
Other outcomes:
measure: Assessment of quality of life at 6-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire
timeFrame: 6 months
measure: Assessment of quality of life at 6-mo follow-up with self-administered EORTC QLQ-C30 questionnaire
timeFrame: 6 months
measure: Assessment of quality of life at 12-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire
timeFrame: 12 months
measure: Assessment of quality of life at 12-mo follow-up with self-administered EORTC QLQ-C30 questionnaire
timeFrame: 12 months
measure: Assessment of quality of life at 24-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire
timeFrame: 24 months
measure: Assessment of quality of life at 24-mo follow-up with self-administered EORTC QLQ-C30 questionnaire
timeFrame: 24 months
measure: Disease free survival
timeFrame: 24 months
measure: Cancer specific survival
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Assessment of urinary continence with pad test.
timeFrame: 12 months
measure: Assessment of urinary continence with pad test.
timeFrame: 24 months
Locations:
city: Rome
country: Italy
facility: Regina Elena NCI
state: Lazio
Study officials:
affiliation: "Regina Elena" National Cancer Institute, Dept of Urology
name: Giuseppe Simone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mastroianni R, Tuderti G, Anceschi U, Bove AM, Brassetti A, Ferriero M, Zampa A, Giannarelli D, Guaglianone S, Gallucci M, Simone G. Comparison of Patient-reported Health-related Quality of Life Between Open Radical Cystectomy and Robot-assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Interim Analysis of a Randomised Controlled Trial. Eur Urol Focus. 2022 Mar;8(2):465-471. doi: 10.1016/j.euf.2021.03.002. Epub 2021 Mar 10.