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Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer

NCT ID: NCT02252393

Last Updated: 2016-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Recurrent Bladder Cancer Stage 0 Bladder Cancer Stage I Bladder Cancer Stage II Bladder Cancer Urinary Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (RARC with IUD)

Patients undergo RARC with IUD.

Group Type EXPERIMENTAL

robot-assisted laparoscopic surgery

Intervention Type PROCEDURE

Undergo RARC with IUD

intraoperative complication management/prevention

Intervention Type OTHER

Undergo RARC with IUD

quality-of-life assessment

Intervention Type OTHER

Ancillary studies

Arm II (RARC with EUD)

Patients undergo RARC with EUD.

Group Type EXPERIMENTAL

robot-assisted laparoscopic surgery

Intervention Type PROCEDURE

Undergo RARC with EUD

intraoperative complication management/prevention

Intervention Type OTHER

Undergo RARC with EUD

quality-of-life assessment

Intervention Type OTHER

Ancillary studies

Interventions

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robot-assisted laparoscopic surgery

Undergo RARC with IUD

Intervention Type PROCEDURE

robot-assisted laparoscopic surgery

Undergo RARC with EUD

Intervention Type PROCEDURE

intraoperative complication management/prevention

Undergo RARC with IUD

Intervention Type OTHER

intraoperative complication management/prevention

Undergo RARC with EUD

Intervention Type OTHER

quality-of-life assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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quality of life assessment

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jihad Kaouk

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Countries

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United States

Other Identifiers

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NCI-2014-01530

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE 7814

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE7814

Identifier Type: -

Identifier Source: org_study_id