Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer

Study Overview
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Brief Summary
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This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion during robotic assisted radical cystectomy in reducing complications in patients with bladder cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a new way for urine to leave the body) is performed. It is not yet known whether intracorporeal (within the body) or extracorporeal (outside of the body) urinary diversion is a better method in patients with bladder cancer undergoing robotic assisted radical cystectomy.

Detailed Description
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PRIMARY OBJECTIVES: I. To compare perioperative outcomes and complications after robotic assisted radical cystectomy (RARC) with intracorporeal urinary diversion (IUD) and RARC with extracorporeal urinary diversion (EUD) in a prospective randomized fashion. SECONDARY OBJECTIVES: I. Time to passage of flatus. II. Analgesic requirement (narcotic use). III. Hospital length of stay. IV. Total operating time. V. Estimated blood loss. VI. Readmission rate. VII. Bladder Cancer Index Questionnaire. VIII. Ureteral strictures. IX. Stomal stenosis. X. Disease recurrence. XI. Secondary procedures. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo RARC with IUD. ARM II: Patients undergo RARC with EUD. After completion of study treatment, patients are followed up within 90 days and then for 2-5 years.

Official Title
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Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy

Conditions
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Recurrent Bladder Cancer, Stage 0 Bladder Cancer, Stage I Bladder Cancer, Stage II Bladder Cancer, Urinary Complications

Intervention / Treatment
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* Procedure: robot-assisted laparoscopic surgery
* Procedure: robot-assisted laparoscopic surgery
* Other: intraoperative complication management/prevention
* Other: intraoperative complication management/prevention
* Other: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Grade G1 - G3 bladder cancer T stage: cTis - T2 N0 M0 American Society of Anesthesiologists (ASA) < 4 Informed consent Eastern Cooperative Oncology Group (ECOG) performance status 2 or better Hemoglobin (Hgb) > 8.0 g/dL White blood cell (WBC) > 2.0 k/uL Platelets > 50,000 Creatinine < 3.0 x upper limit of normal (ULN) Aspartate aminotransferase (AST) < 5.0 x ULN Alanine transaminase (ALT) < 5.0 x ULN Exclusion Criteria: Patient unsuitable for or refusing radical cystectomy T stage ≥ T3 (mass extending outside the bladder) Gross nodal or metastatic disease at presentation (≥ N1, M1) Prior pelvic radiation Prior open or laparoscopic/robotic bladder or prostate surgery Prior colorectal surgery or history of inflammatory bowel disease Body mass index (BMI) ≥ 40 ECOG performance status 3 or worse History of coagulopathy or bleeding disorders Chronic steroid use Patients with end stage renal disease (ESRD) and/or on dialysis
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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (RARC with IUD)<br>Patients undergo RARC with IUD. | Procedure: robot-assisted laparoscopic surgery<br>* Undergo RARC with IUD<br>Other: intraoperative complication management/prevention<br>* Undergo RARC with IUD<br>Other: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|
| Experimental: Arm II (RARC with EUD)<br>Patients undergo RARC with EUD. | Procedure: robot-assisted laparoscopic surgery<br>* Undergo RARC with EUD<br>Other: intraoperative complication management/prevention<br>* Undergo RARC with EUD<br>Other: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Analyzed using multivariable logistical regression. Descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for adverse event reporting. | 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to passage of flatus | Analyzed using regression analysis. | Up to 90 days | 
| Analgesic requirement (narcotic use) | Analyzed using logistical regression. | Up to 90 days | 
| Hospital length of stay | Analyzed using regression analysis. | Up to 90 days | 
| Total operating time | Analyzed using regression analysis. | Up to completion of surgery | 
| Estimated blood loss | Analyzed using regression analysis. | Up to 90 days | 
| Readmission rate | Analyzed using regression analysis. | Up to 90 days | 
| Quality of life assessed using the Bladder Cancer Index Questionnaire | The Cox proportional hazards model will be used. The hazard ratio (HR) and 95% confidence interval (95% CI) associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated. | Up to 5 years | 
| Ureteral strictures | The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated. | Up to 5 years | 
| Stromal stenosis | The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated. | Up to 5 years | 
| Disease recurrence | The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated. | Up to 5 years | 
| Secondary procedures | The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated. | Up to 5 years | 
| Cumulative complication incidence | Graphically described using the Kaplan-Meier method. Descriptions and grading scales found in the NCI CTCAE version 4.0 will be utilized for adverse event reporting. | Up to 5 years |