Randomized Trial Comparing Robotic and Open Radical Cystectomy

Phase 3

Completed

• Conditions: Bladder Cancer
• Interventions: Procedure: open radical cystectomy; Procedure: robotic-assisted radical cystectomy

• Registration Number: NCT01076387
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-26
• Status Verified: 2020-03
• Primary Completion: 2020-03-12
• Study Completion: 2020-03-12
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Age > 18 years.
• Scheduled for radical cystectomy at MSKCC

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open radical cystectomy	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.
robotic-assisted radical cystectomy	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.

Primary Outcome Measures

Name	Time	Method
To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.	intraoperative and 90-day postoperative period

Secondary Outcome Measures

Name	Time	Method
To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy.	2 years
complications grade 2-5	2 years	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.
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	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States