NCT02252393

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

Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2014-09-30
• Last updated: 2016-11-09