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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Studer Pouch | Experimental | Studer Pouch orthotopic urinary diversion |
|
| T-Pouch | Experimental | T-Pouch orthotopic urinary diversion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Studer Pouch orthotopic urinary diversion | Procedure |
| ||
| T-Pouch orthotopic urinary diversion |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the long-term outcome (> 3 years) as it pertains to renal function, anatomy of the upper urinary tracts, and the requirement for medical or surgical intervention (ie for symptomatic urinary tract infections). | 3 years after date of last patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| A secondary endpoint is the length of surgery and the incidence of early postoperative complications (<30 days from surgery) believed to be related to the type of urinary diversion. | Within 30 days after surgery | |
| An additional secondary endpoint is cancer recurrence and overall survival, which will be recorded in each patient. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siamak Daneshmand, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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| Procedure |
|
| Yearly for the first 5 years, then every 2 years |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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