NCT01076387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

10.1 years

First QC Date

February 24, 2010

Last Update Submit

March 12, 2020

Conditions

Bladder Cancer

Keywords

BladderCystectomyRoboticOpen Radical10-016

Outcome Measures

Primary Outcomes (1)

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

    intraoperative and 90-day postoperative period

Secondary Outcomes (6)

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

    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

  • complications grade 2-5

    2 years

  • +1 more secondary outcomes

Study Arms (2)

open radical cystectomy

ACTIVE COMPARATOR

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

Procedure: open radical cystectomy

robotic-assisted radical cystectomy

ACTIVE COMPARATOR

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

Procedure: robotic-assisted radical cystectomy

Interventions

open radical cystectomyPROCEDURE

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

open radical cystectomy
robotic-assisted radical cystectomyPROCEDURE

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.

robotic-assisted radical cystectomy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • 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.

    PMID: 25496767DERIVED

Related Links

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Vincent Laudone, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 26, 2010

Study Start

February 1, 2010

Primary Completion

March 12, 2020

Study Completion

March 12, 2020

Last Updated

March 16, 2020

Record last verified: 2020-03

Locations

US(1)