Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer
Conditions
Recurrent Bladder Cancer - Stage 0 Bladder Cancer - Stage I Bladder Cancer - Stage II Bladder Cancer - Urinary Complications
Conditions: official terms
Urinary Bladder Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: robot-assisted laparoscopic surgery Type: Procedure
Name: robot-assisted laparoscopic surgery Type: Procedure
Name: intraoperative complication management/prevention Type: Other
Name: intraoperative complication management/prevention Type: Other
Name: quality-of-life assessment Type: Other
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: 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
Location
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Status: Not yet recruiting
Contact: Jihad Kaouk - 216-444-2976 - kaoukj@ccf.org
Start Date
May 2015
Sponsors
Case Comprehensive Cancer Center
Source
Case Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page