Clinical trial NCT02252393: Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer
Official title: Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Recurrent Bladder Cancer
Stage 0 Bladder Cancer
Stage I Bladder Cancer
Stage II Bladder Cancer
Urinary Complications
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-09-30
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Complication rate
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Time to passage of flatus
timeFrame: Up to 90 days
measure: Analgesic requirement (narcotic use)
timeFrame: Up to 90 days
measure: Hospital length of stay
timeFrame: Up to 90 days
measure: Total operating time
timeFrame: Up to completion of surgery
measure: Estimated blood loss
timeFrame: Up to 90 days
measure: Readmission rate
timeFrame: Up to 90 days
measure: Quality of life assessed using the Bladder Cancer Index Questionnaire
timeFrame: Up to 5 years
measure: Ureteral strictures
timeFrame: Up to 5 years
measure: Stromal stenosis
timeFrame: Up to 5 years
measure: Disease recurrence
timeFrame: Up to 5 years
measure: Secondary procedures
timeFrame: Up to 5 years
measure: Cumulative complication incidence
timeFrame: Up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Jihad Kaouk
role: PRINCIPAL_INVESTIGATOR
References: