Bladder Cancer
Conditions
Brief 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.
Interventions
PROCEDUREStuder Pouch orthotopic urinary diversion
PROCEDURET-Pouch orthotopic urinary diversion
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients undergoing radical cystectomy for bladder cancer who are considered candidates for a neobladder reconstruction are eligible for enrollment. * Diagnosed with primary bladder cancer (any histology). * Scheduled to undergo a radical cystectomy (cystoprostatectomy in men and anterior exenteration in women). * Felt by the treating physician to be a candidate for an orthotopic neobladder urinary diversion. * Be competent and willing to sign the informed consent. * Patients may have received previous radiation therapy or intravesical or systemic chemotherapy. Patients with documented metastatic disease are not excluded as long as they are felt to be candidates for a continent neobladder urinary diversion.
Exclusion criteria
* Patients undergoing radical cystectomy for any malignancy other than primary bladder cancer (for example prostate cancer or colon cancer invading the bladder,or a gynecologic malignancy), or non-malignant disease (such as a neurogenic bladder or radiation cystitis). * Unwilling or unable to sign the informed consent. * Not eligible for an orthotopic neobladder reconstruction. * A history of other malignancy (except for stage I cancer treated with curative intent without evidence of recurrence, clinically localized prostate cancer either untreated or treated with prostatectomy or radiation therapy or hormone therapy,or non-melanoma skin cancer) within the previous 5 years.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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. | Yearly for the first 5 years, then every 2 years |
Countries
United States
Outcome results
None listed