Recurrent Bladder Cancer, Stage 0 Bladder Cancer, Stage I Bladder Cancer, Stage II Bladder Cancer, Urinary Complications
Conditions
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.
Interventions
PROCEDURErobot-assisted laparoscopic surgery
Undergo RARC with IUD
Undergo RARC with IUD
OTHERquality-of-life assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Analgesic requirement (narcotic use) | Up to 90 days | Analyzed using logistical regression. |
| Hospital length of stay | Up to 90 days | Analyzed using regression analysis. |
| Total operating time | Up to completion of surgery | Analyzed using regression analysis. |
| Estimated blood loss | Up to 90 days | Analyzed using regression analysis. |
| Readmission rate | Up to 90 days | Analyzed using regression analysis. |
| Time to passage of flatus | 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. |
| 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. |
| 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. |
| 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. |
Outcome results
None listed