Recurrent Bladder Cancer Clinical Trial
Official title:
Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy
Verified date | November 2016 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complication rate | 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. | 90 days after surgery | Yes |
Secondary | Time to passage of flatus | Analyzed using regression analysis. | Up to 90 days | No |
Secondary | Analgesic requirement (narcotic use) | Analyzed using logistical regression. | Up to 90 days | No |
Secondary | Hospital length of stay | Analyzed using regression analysis. | Up to 90 days | No |
Secondary | Total operating time | Analyzed using regression analysis. | Up to completion of surgery | No |
Secondary | Estimated blood loss | Analyzed using regression analysis. | Up to 90 days | No |
Secondary | Readmission rate | Analyzed using regression analysis. | Up to 90 days | No |
Secondary | Quality of life assessed using the Bladder Cancer Index Questionnaire | 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. | Up to 5 years | No |
Secondary | Ureteral strictures | 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. | Up to 5 years | No |
Secondary | Stromal stenosis | 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. | Up to 5 years | No |
Secondary | Disease recurrence | 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. | Up to 5 years | No |
Secondary | Secondary procedures | 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. | Up to 5 years | No |
Secondary | Cumulative complication incidence | 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. | Up to 5 years | Yes |
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