Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer
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About
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.
Full 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.
Sex
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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