Randomized Trial Comparing Robotic and Open Radical Cystectomy

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 3

Conditions: Bladder Cancer

Treatments: Procedure: robotic-assisted radical cystectomy; Procedure: open radical cystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01076387

10-016

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

open radical cystectomy

Active Comparator group

Description:

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

Treatment:

Procedure: open radical cystectomy

robotic-assisted radical cystectomy

Active Comparator group

Description:

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

Treatment:

Procedure: robotic-assisted radical cystectomy