Randomized Trial Comparing Robotic and Open Radical Cystectomy

Memorial Sloan Kettering Cancer Center124 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

124

Conditions

Bladder Cancer

Interventions

open radical cystectomyPROCEDURE

Open radical cystectomy, pelvic lymph node dissection and open urinary diversion.

robotic-assisted radical cystectomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.

Time frame: intraoperative and 90-day postoperative period

Secondary Outcomes

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

A secondary analysis will be used to determine if the total burden of grade 2-5 complications in the robotic arm is different from the open arm.

Time frame: 2 years

complication grade 3-5

Determine if there is a difference in either the number of patients with grade 3-5 complication or the total number of grade 3-5 complication in the two arms of the study.

Time frame: 2 years

Data from ClinicalTrials.gov

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