Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer
- Conditions
- Stage I Bladder CancerStage II Bladder CancerUrinary ComplicationsRecurrent Bladder CancerStage 0 Bladder Cancer
- Interventions
- Procedure: robot-assisted laparoscopic surgeryOther: intraoperative complication management/preventionOther: quality-of-life assessment
- Registration Number
- NCT02252393
- Lead Sponsor
- Case Comprehensive Cancer Center
- 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.
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (RARC with IUD) intraoperative complication management/prevention Patients undergo RARC with IUD. Arm II (RARC with EUD) quality-of-life assessment Patients undergo RARC with EUD. Arm II (RARC with EUD) robot-assisted laparoscopic surgery Patients undergo RARC with EUD. Arm II (RARC with EUD) intraoperative complication management/prevention Patients undergo RARC with EUD. Arm I (RARC with IUD) robot-assisted laparoscopic surgery Patients undergo RARC with IUD. Arm I (RARC with IUD) quality-of-life assessment Patients undergo RARC with IUD.
- Primary Outcome Measures
Name Time Method Complication rate 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 Outcome Measures
Name Time Method Hospital length of stay Up to 90 days Analyzed using regression analysis.
Ureteral strictures Up to 5 years 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.
Disease recurrence Up to 5 years 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.
Secondary procedures Up to 5 years 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.
Cumulative complication incidence Up to 5 years 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 to passage of flatus Up to 90 days Analyzed using regression analysis.
Total operating time Up to completion of surgery Analyzed using regression analysis.
Stromal stenosis Up to 5 years 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.
Readmission rate Up to 90 days Analyzed using regression analysis.
Analgesic requirement (narcotic use) Up to 90 days Analyzed using logistical regression.
Estimated blood loss Up to 90 days Analyzed using regression analysis.
Quality of life assessed using the Bladder Cancer Index Questionnaire Up to 5 years 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.