A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy

Memorial Sloan Kettering Cancer Center1 site in 1 country124 target enrollmentFebruary 2010

ConditionsBladder Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Bladder Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 124
Locations: 1
Primary Endpoint: To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

March 12, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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

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.(2 years)
complications grade 2-5(2 years)
Intra-operative performance (surgical time, blood loss)(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.(1.5 years)
Bladder cancer recurrence (local, upper tract and distant disease)(2 years)
complication grade 3-5(2 years)