Randomized Trial Comparing Robotic and Open Radical Cystectomy

Overview

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.

Full Title of Study: “A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 12, 2020

Interventions

  • Procedure: open radical cystectomy
    • Open radical cystectomy, pelvic lymph node dissection and open urinary diversion.
  • Procedure: robotic-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.

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.
    • Time Frame: intraoperative and 90-day postoperative period

Secondary Measures

  • To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy.
    • Time Frame: 2 years
  • Intra-operative performance (surgical time, blood loss)
    • Time Frame: 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.
    • Time Frame: 1.5 years
  • Bladder cancer recurrence (local, upper tract and distant disease)
    • Time Frame: 2 years
  • complications grade 2-5
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vincent Laudone, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center

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