NCT03434132

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

Completed NA Last updated 19 January 2023

What this trial tests

NA trial testing Open or robotic radical cystectomy in Bladder Cancer in 116 participants. Completed in 30 September 2022.

Timeline

29 January 2018

Primary endpoint
30 October 2020

30 September 2022

Quick facts

Lead sponsor	Regina Elena Cancer Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	116
Start date	29 January 2018
Primary completion	30 October 2020
Estimated completion	30 September 2022
Sites	1 location across Italy

Drugs / interventions tested

• Open or robotic radical cystectomy

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

Regina Elena Cancer Institute

Who can join

Eligibility, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Open Radical Cystectomy versus Robot-Assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Early Outcomes of a Single-Center Randomized Controlled Trial.
   Mastroianni R, Ferriero M, Tuderti G, Anceschi U, et al · · 2022 · cited 99× · PMID 34986007 · DOI 10.1097/ju.0000000000002422
2. 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.
   Mastroianni R, Tuderti G, Anceschi U, Bove AM, et al · · 2022 · cited 64× · PMID 33712389 · DOI 10.1016/j.euf.2021.03.002
3. Late complications of robot-assisted radical cystectomy with totally intracorporeal urinary diversion.
   Presicce F, Leonardo C, Tuderti G, Brassetti A, et al · · 2021 · cited 20× · PMID 32747981 · DOI 10.1007/s00345-020-03378-7
4. Health Related Quality of Life in Patients with Bladder Cancer Receiving a Radical Cystectomy.
   Mastroianni R, Iannuzzi A, Ragusa A, Tuderti G, et al · · 2023 · cited 7× · PMID 38136375 · DOI 10.3390/cancers15245830
5. Detubularized Ureterosigmoidostomy for the Creation of Continent Neobladder in Children: Cases Report and Review of the Literature.
   Bindi E, Ilari M, Torino G, Mariscoli F, et al · · 2021 · cited 3× · PMID 33916416 · DOI 10.3390/children8040279
6. Advances in bladder substitution and creation of neobladders in children.
   Reifsnyder JE, Hanna MK. · · 2019 · cited 3× · PMID 31824647 · DOI 10.12688/f1000research.16607.1