A Comparison of the Studer Pouch Versus the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients
NCT01008865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 529
Last updated 2019-01-25
Summary
This is a prospective, randomized study of two types of continent ileal neobladder construction in patients undergoing cystectomy for primary bladder cancer. Patients will be randomly assigned to have either a T-pouch or a Studer pouch constructed at the time of their surgery. They will be followed long-term to determine the relative advantages and disadvantages of the two types of diversion. The investigators' hypothesis is that the inclusion of an antireflux mechanism in the T-pouch will result in significantly fewer episodes of symptomatic urinary tract infection, and will have a lower incidence of upper tract dilation and loss of renal function over the long term.
Conditions
Interventions
- PROCEDURE
-
Studer Pouch orthotopic urinary diversion
- PROCEDURE
-
T-Pouch orthotopic urinary diversion
Sponsors & Collaborators
-
University of Southern California
lead OTHER
Principal Investigators
-
Siamak Daneshmand, MD · University of Southern California
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-01-04
- Primary Completion
- 2018-06-14
- Completion
- 2018-06-14
Countries
- United States
Study Locations
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