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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Undergo RARC with IUD
Undergo RARC with EUD
Undergo RARC with IUD
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.
Time frame: 90 days after surgery
Time to passage of flatus
Analyzed using regression analysis.
Time frame: Up to 90 days
Analgesic requirement (narcotic use)
Analyzed using logistical regression.
Time frame: Up to 90 days
Hospital length of stay
Analyzed using regression analysis.
Time frame: Up to 90 days
Total operating time
Analyzed using regression analysis.
Time frame: Up to completion of surgery
Estimated blood loss
Analyzed using regression analysis.
Time frame: Up to 90 days
Readmission rate
Analyzed using regression analysis.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Undergo RARC with EUD
Ancillary studies
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years