Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion.

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Procedure: Open or robotic radical cystectomy

• Registration Number: NCT03434132
• Lead Sponsor: Regina Elena Cancer Institute

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.

Study Timeline

• Study First Submitted: 2018-01-26
• Study Start: 2018-01-29
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-15
• Primary Completion: 2020-10-30
• Study Completion: 2022-09-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot assisted radical cystectomy	Open or robotic radical cystectomy	Robot assisted radical cystectomy, pelvic lymph node dissection, intracorporeal urinary diversion (neobladder or ileal conduit)
Open Radical Cystectomy	Open or robotic radical cystectomy	Open Radical Cystectomy, pelvic lymph node dissection, urinary diversion (neobladder or ileal conduit)

Primary Outcome Measures

Name	Time	Method
Number of participants requiring perioperative transfusions.	30 days	50% reduction of perioperative transfusion rates in robotic arm.

Secondary Outcome Measures

Name	Time	Method
Number of participants requiring insertion of nasogastric tube	30 days	Comparison between open and robotic arms.
Incidence of Clavien grade 1-2 perioperative complications at 180-d evaluation.	180 days	Comparison between open and robotic arms.
Incidence of Clavien grade 1-2 perioperative complications at 90-d evaluation.	90 days	Comparison between open and robotic arms.
Cost analysis.	30 days	Comparison between open and robotic arms.
Incidence of Clavien grade 1-2 perioperative complications at 30-d evaluation.	30 days	Comparison between open and robotic arms.
Incidence of patients requiring readmission.	90 days	Comparison between open and robotic arms.

Trial Locations

Locations (1)

Regina Elena NCI; 🇮🇹 Rome, Lazio, Italy