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Randomized Trial Comparing Robotic and Open Radical Cystectomy

Primary Purpose

Bladder Cancer

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

open radical cystectomy

robotic-assisted radical cystectomy

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Bladder, Cystectomy, Robotic, Open Radical, 10-016

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

open radical cystectomy

robotic-assisted radical cystectomy

Arm Description

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

Outcomes

Primary Outcome Measures

To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.

Secondary Outcome Measures

To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy.

Intra-operative performance (surgical time, blood loss)

Pathologic findings, including the stage specific, soft tissue surgical margin rate and number of lymph nodes removed.

Bladder cancer recurrence (local, upper tract and distant disease)

complications grade 2-5

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

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.

Full Information

NCT ID

NCT01076387

First Posted

February 24, 2010

Last Updated

March 12, 2020

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01076387

Brief Title

Randomized Trial Comparing Robotic and Open Radical Cystectomy

Official Title

A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

February 2010 (Actual)

Primary Completion Date

March 12, 2020 (Actual)

Study Completion Date

March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

open radical cystectomy

Arm Type

Active Comparator

Arm Description

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

Arm Title

robotic-assisted radical cystectomy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

open radical cystectomy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

robotic-assisted radical cystectomy

Intervention Description

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.

Primary Outcome Measure Information:

Title

To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.

Time Frame

intraoperative and 90-day postoperative period

Secondary Outcome Measure Information:

Title

To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy.

Time Frame

2 years

Title

Intra-operative performance (surgical time, blood loss)

Time Frame

time from anesthesia induction to final skin closure

Title

Pathologic findings, including the stage specific, soft tissue surgical margin rate and number of lymph nodes removed.

Time Frame

1.5 years

Title

Bladder cancer recurrence (local, upper tract and distant disease)

Time Frame

2 years

Title

complications grade 2-5

Description

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.

Time Frame

2 years

Title

complication grade 3-5

Description

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.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vincent Laudone, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25496767

Citation

Bochner BH, Dalbagni G, Sjoberg DD, Silberstein J, Keren Paz GE, Donat SM, Coleman JA, Mathew S, Vickers A, Schnorr GC, Feuerstein MA, Rapkin B, Parra RO, Herr HW, Laudone VP. Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial. Eur Urol. 2015 Jun;67(6):1042-1050. doi: 10.1016/j.eururo.2014.11.043. Epub 2014 Dec 8.

Results Reference

derived

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

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Randomized Trial Comparing Robotic and Open Radical Cystectomy

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