Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Complication rate
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Grade G1 - G3 bladder cancer
- •T stage: cTis - T2
- •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
Outcomes
Primary Outcomes
Complication rate
Time Frame: 90 days after surgery
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.
Secondary Outcomes
- Hospital length of stay(Up to 90 days)
- Ureteral strictures(Up to 5 years)
- Disease recurrence(Up to 5 years)
- Secondary procedures(Up to 5 years)
- Cumulative complication incidence(Up to 5 years)
- Time to passage of flatus(Up to 90 days)
- Total operating time(Up to completion of surgery)
- Stromal stenosis(Up to 5 years)
- Readmission rate(Up to 90 days)
- Analgesic requirement (narcotic use)(Up to 90 days)
- Estimated blood loss(Up to 90 days)
- Quality of life assessed using the Bladder Cancer Index Questionnaire(Up to 5 years)