Randomized Trial Comparing Robotic and Open Radical Cystectomy

A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01076387

Enrollment

124

Registered

2010-02-26

Start date

2010-02-28

Completion date

2020-03-12

Last updated

2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Bladder, Cystectomy, Robotic, Open Radical, 10-016

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.

Interventions

PROCEDUREopen radical cystectomy

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

PROCEDURErobotic-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—
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.
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.
Bladder cancer recurrence (local, upper tract and distant disease)	2 years	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026