Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT02252393
Status:
WITHDRAWN
Last Update Posted:
2016-11-09
First Post:
2014-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy
Status:
WITHDRAWN
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
waiting on surgeon training
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-01530 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CASE 7814 | OTHER | Case Comprehensive Cancer Center | View | |
| P30CA043703 | NIH | None | https://reporter.nih.gov/quic… | View |