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

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.

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