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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Recurrent Bladder Cancer; Urinary Complications; Stage 0 Bladder Cancer; Stage I Bladder Cancer; Stage II Bladder Cancer
• Intervention / Treatment: Other: quality-of-life assessment; Procedure: robot-assisted laparoscopic surgery; Procedure: robot-assisted laparoscopic surgery; Other: intraoperative complication management/prevention; Other: intraoperative complication management/prevention

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: September 26, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimate): September 30, 2014

Study Record Updates

• Last Update Posted (Estimate): November 9, 2016
• Last Update Submitted That Met QC Criteria: November 8, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: CASE7814; P30CA043703 (U.S. NIH Grant/Contract); NCI-2014-01530 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CASE 7814 (Other Identifier: Case Comprehensive Cancer Center)