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

NCT02252393 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-11-09

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

robot-assisted laparoscopic surgery

Undergo RARC with IUD

PROCEDURE

robot-assisted laparoscopic surgery

Undergo RARC with EUD

OTHER

intraoperative complication management/prevention

Undergo RARC with IUD

OTHER

intraoperative complication management/prevention

Undergo RARC with EUD

OTHER

quality-of-life assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Jihad Kaouk · Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-11-30
Completion
2016-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02252393 on ClinicalTrials.gov