Overview

This trial is active, not recruiting.

Condition bladder cancer
Treatments open radical cystectomy, robotic-assisted radical cystectomy
Phase phase 3
Sponsor Memorial Sloan Kettering Cancer Center
Start date February 2010
End date February 2017
Trial size 124 participants
Trial identifier NCT01076387, 10-016

Summary

The purpose of this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. The removal of the bladder and lymph nodes will be done by a robotic or by an open technique. It may be a Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer.
open radical cystectomy
Open radical cystectomy, pelvic lymph node dissection and open urinary diversion.
(Active Comparator)
This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer.
robotic-assisted radical cystectomy
Robotic radical cystectomy, pelvic lymph node dissection and open urinary diversion. Robotic radical cystectomy is routinely performed by robotically trained and experienced minimally invasive surgeons.

Primary Outcomes

Measure
To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.
time frame: intraoperative and 90-day postoperative period

Secondary Outcomes

Measure
To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy.
time frame: 2 years
Intra-operative performance (surgical time, blood loss)
time frame: time from anesthesia induction to final skin closure
Pathologic findings, including the stage specific, soft tissue surgical margin rate and number of lymph nodes removed.
time frame: 1.5 years
Bladder cancer recurrence (local, upper tract and distant disease)
time frame: 2 years
complications grade 2-5
time frame: 2 years
complication grade 3-5
time frame: 2 years

Eligibility Criteria

Male or female participants at least 19 years old.

Inclusion Criteria: - Age > 18 years. - Scheduled for radical cystectomy at MSKCC Exclusion Criteria: - Prior pelvic or abdominal radiation therapy; - Prior extensive open abdominal surgery, defined by the discretion of the attending surgeon - Any clinical contraindication for Trendelenburg positioning

Additional Information

Official title A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy
Principal investigator Vincent Laudone, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.