Randomized Trial Comparing Robotic and Open Radical Cystectomy

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: open radical cystectomy
* Procedure: robotic-assisted radical cystectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: open radical cystectomy<br>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<br>* Open radical cystectomy, pelvic lymph node dissection and open urinary diversion.<br>|
| Active Comparator: robotic-assisted radical cystectomy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 2 years | 
| 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder, Cystectomy, Robotic, Open Radical, 10-016