Randomized Trial Comparing Robotic and Open Radical Cystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2020-03-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open radical cystectomy

This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer.

Group Type ACTIVE_COMPARATOR

open radical cystectomy

Intervention Type PROCEDURE

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

robotic-assisted radical cystectomy

This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer.

Group Type ACTIVE_COMPARATOR

robotic-assisted radical cystectomy

Intervention Type PROCEDURE

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.

Interventions

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open radical cystectomy

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No