Status:
WITHDRAWN
Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Bladder Cancer
Stage 0 Bladder Cancer
Eligibility:
All Genders
Phase:
NA
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 ...
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 ur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02252393
Start Date
October 1 2015
End Date
November 1 2016
Last Update
November 9 2016
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