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

Bladder Cancer Clinical Trial

Official title:

Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion. Single Centre Prospective Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434132
• Other study ID #: GR2016-02364306
• Status: Completed
• Phase: N/A
• Start date: January 29, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2023
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: September 30, 2022
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Open or robotic radical cystectomy
ORC and orthotopic ileal neobladder is performed as previously described. A separate package PLND is performed as in open as in robotic surgery. RARC is performed replicating open surgical procedure. The orthotopic ileal neobladder model used is the 'vescica ileale padovana' as previously described. An ileal segment, approximately 42 cm long, is chosen at a minimum distance of 20cm far from ileo-cecal valve. A latero-lateral ileal anastomosis is performed with staplers to restore bowel continuity. For ileal conduit, a 20cm ileal segment (approximately 20 cm long) at a minimum distance of 20 cm from ileo-cecal valve is isolated and transected with staplers. Bowel continuity is restored as previously described. The ileal loop on its distal edge is extracted through abdomen wall at the previously identified stoma point and fixed to abdomen fascia. The ureters are spatulated and a latero-lateral anastomosis according to Wallace 1 technique is performed.

Locations

Country	Name	City	State
Italy	Regina Elena NCI	Rome	Lazio

Sponsors (2)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute	Ministero della Salute, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of quality of life at 6-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire	Comparison between open and robotic arms.	6 months
Other	Assessment of quality of life at 6-mo follow-up with self-administered EORTC QLQ-C30 questionnaire	Comparison between open and robotic arms.	6 months
Other	Assessment of quality of life at 12-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire	Comparison between open and robotic arms.	12 months
Other	Assessment of quality of life at 12-mo follow-up with self-administered EORTC QLQ-C30 questionnaire	Comparison between open and robotic arms.	12 months
Other	Assessment of quality of life at 24-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire	Comparison between open and robotic arms.	24 months
Other	Assessment of quality of life at 24-mo follow-up with self-administered EORTC QLQ-C30 questionnaire	Comparison between open and robotic arms.	24 months
Other	Disease free survival	Comparison between open and robitic arms	24 months
Other	Cancer specific survival	Comparison between open and robitic arms	24 months
Other	Overall survival	Comparison between open and robitic arms	24 months
Other	Assessment of urinary continence with pad test.	Comparison between open and robotic arms	12 months
Other	Assessment of urinary continence with pad test.	Comparison between open and robotic arms	24 months
Primary	Number of participants requiring perioperative transfusions.	50% reduction of perioperative transfusion rates in robotic arm.	30 days
Secondary	Number of participants requiring insertion of nasogastric tube	Comparison between open and robotic arms.	30 days
Secondary	Incidence of Clavien grade 1-2 perioperative complications at 30-d evaluation.	Comparison between open and robotic arms.	30 days
Secondary	Incidence of Clavien grade 1-2 perioperative complications at 90-d evaluation.	Comparison between open and robotic arms.	90 days
Secondary	Incidence of Clavien grade 1-2 perioperative complications at 180-d evaluation.	Comparison between open and robotic arms.	180 days
Secondary	Incidence of patients requiring readmission.	Comparison between open and robotic arms.	90 days
Secondary	Cost analysis.	Comparison between open and robotic arms.	30 days