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

NCT03434132 | Completed

• 1 other identifier: GR2016-02364306
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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).

Conditions

Bladder Cancer

Keywords

Open Radical Cystectomy; Robotic Radical cystectomy; Intracorporeal urinary diversion; Prospective randdomized trial

Outcome Measures

Primary Outcomes (1)

• Number of participants requiring perioperative transfusions.

  50% reduction of perioperative transfusion rates in robotic arm.

  30 days

Secondary Outcomes (6)

• Number of participants requiring insertion of nasogastric tube

  30 days

• Incidence of Clavien grade 1-2 perioperative complications at 30-d evaluation.

  30 days

• Incidence of Clavien grade 1-2 perioperative complications at 90-d evaluation.

  90 days

• Incidence of Clavien grade 1-2 perioperative complications at 180-d evaluation.

  180 days

• Incidence of patients requiring readmission.

  90 days

Other Outcomes (11)

• Assessment of quality of life at 6-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire

  6 months

• Assessment of quality of life at 6-mo follow-up with self-administered EORTC QLQ-C30 questionnaire

  6 months

• Assessment of quality of life at 12-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire

  12 months

Study Arms (2)

Open Radical Cystectomy

ACTIVE COMPARATOR

Open Radical Cystectomy, pelvic lymph node dissection, urinary diversion (neobladder or ileal conduit)

Procedure: Open or robotic radical cystectomy

Robot assisted radical cystectomy

EXPERIMENTAL

Robot assisted radical cystectomy, pelvic lymph node dissection, intracorporeal urinary diversion (neobladder or ileal conduit)

Procedure: Open or robotic radical cystectomy

Interventions

Open or robotic radical cystectomy PROCEDURE

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.

Open Radical Cystectomy; Robot assisted radical cystectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with muscle invasive high grade urothelial carcinoma (and variant histologies) of the bladder or high grade non muscle invasive BCG recurrent/refractory disease.

You may not qualify if:

• Cystectomy without curative intent (palliative, salvage).
• Patients unfit for robotic cystectomy.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Ministero della Salute, Italy: collaborator

Study Sites (1)

Regina Elena NCI

Rome, Lazio, 00144, Italy

Location

Related Publications (1)

• 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.

  PMID: 33712389 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Giuseppe Simone, PhD

  "Regina Elena" National Cancer Institute, Dept of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, COnsultant Urologist

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 15, 2018
• Study Start: January 29, 2018
• Primary Completion: October 30, 2020
• Study Completion: September 30, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)