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Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

NCT ID: NCT01157676

Last Updated: 2020-11-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2018-12-31

Brief Summary

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This is a multi-institutional, randomized trial evaluating oncologic, perioperative, and functional outcomes following two standard care procedures for radical cystectomy. The participants will have one of the standard care procedures as part of their care. The two procedures that will be followed are open radical cystectomy and robotic assisted radical cystectomy (RARC). Open cystectomy is considered to be the more traditional approach. While newer, RARC is considered to be equivalent to open surgery when it is performed by a trained robotics surgeon. The reported complication rates of RARC appear comparable to open surgery. This means there is no significant difference in the risk between the two standard procedures. However, despite these potential advantages, true comparison between the open and robotic technique with regards to long term cancer related and functional outcomes has not been accomplished because previous studies did not compare patients of equal health status. The researchers hope to learn whether or not patients undergoing RARC recover more quickly than or at the same rate as patients undergoing an open radical cystectomy while having non inferior cancer related outcomes. This study is funded by the National Institutes of Health (NIH).

Detailed Description

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Conditions

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Bladder Cancer Requiring Cystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non inferiority phase 3 randomized clinical trial comparing robotic to open radical cystectomy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open cystectomy

Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.

Group Type ACTIVE_COMPARATOR

Open radical cystectomy

Intervention Type PROCEDURE

Standard of care removal of urinary bladder.

Robotic assisted radical cystectomy

Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.

Group Type ACTIVE_COMPARATOR

Robotic assisted radical cystectomy

Intervention Type PROCEDURE

Standard of care removal of urinary bladder using DaVinci robot.

DaVinci robot

Intervention Type DEVICE

DaVinci robotic surgical system.

Interventions

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Open radical cystectomy

Standard of care removal of urinary bladder.

Intervention Type PROCEDURE

Robotic assisted radical cystectomy

Standard of care removal of urinary bladder using DaVinci robot.

Intervention Type PROCEDURE

DaVinci robot

DaVinci robotic surgical system.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient must have biopsy proven bladder cancer. Official pathology report reviewed at the participating institution is required.
2. Bladder cancer must be clinical stage T1-T4, N0-1, M0. (AJCC 7th edition) or refractory cis (carcinoma in situ).

Exclusion Criteria

1. Inability to give informed consent.
2. Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
3. At the discretion of the treating surgeon, any pre-existing condition such as severe chronic obstructive pulmonary disease that precludes a safe initiation or maintenance of pneumoperitoneum over a prolonged period of time and during surgery.
4. Age \<18 or \>99 years.
5. Pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Dipen J Parekh, MD

Chairman of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dipen J Parekh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Mayo Clinic Arizona

Phoenix, Arizona, United States

Site Status

University of California, Irvine Medical Center (UC Irvine)

Orange, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center

San Antonio, Texas, United States

Site Status

University of Virginia Health Science Center, Department of Urology

Charlottesville, Virginia, United States

Site Status

Cancer Research and Biostatistics (Data Management and Statistical Office)

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Venkatramani V, Reis IM, Gonzalgo ML, Swain S, Svatek RS, Parekh DJ. Comparison of Complication and Readmission Rates Between Robot-Assisted and Open Radical Cystectomy: Results From the Randomized RAZOR Clinical Trial. J Urol. 2025 Jun;213(6):684-692. doi: 10.1097/JU.0000000000004497. Epub 2025 Mar 13.

Reference Type DERIVED
PMID: 40080805 (View on PubMed)

Venkatramani V, Reis IM, Gonzalgo ML, Castle EP, Woods ME, Svatek RS, Weizer AZ, Konety BR, Tollefson M, Krupski TL, Smith ND, Shabsigh A, Barocas DA, Quek ML, Dash A, Parekh DJ. Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2148329. doi: 10.1001/jamanetworkopen.2021.48329.

Reference Type DERIVED
PMID: 35171260 (View on PubMed)

Parekh DJ, Reis IM, Castle EP, Gonzalgo ML, Woods ME, Svatek RS, Weizer AZ, Konety BR, Tollefson M, Krupski TL, Smith ND, Shabsigh A, Barocas DA, Quek ML, Dash A, Kibel AS, Shemanski L, Pruthi RS, Montgomery JS, Weight CJ, Sharp DS, Chang SS, Cookson MS, Gupta GN, Gorbonos A, Uchio EM, Skinner E, Venkatramani V, Soodana-Prakash N, Kendrick K, Smith JA Jr, Thompson IM. Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial. Lancet. 2018 Jun 23;391(10139):2525-2536. doi: 10.1016/S0140-6736(18)30996-6.

Reference Type DERIVED
PMID: 29976469 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01CA155388

Identifier Type: NIH

Identifier Source: secondary_id

View Link

36911

Identifier Type: OTHER

Identifier Source: secondary_id

20120408

Identifier Type: -

Identifier Source: org_study_id