A Comparison of the Studer Pouch Versus the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients
This trial is active, not recruiting.
|Treatments||studer pouch orthotopic urinary diversion, t-pouch orthotopic urinary diversion|
|Sponsor||University of Southern California|
|Start date||January 2002|
|End date||December 2015|
|Trial size||529 participants|
|Trial identifier||NCT01008865, 4B-01-2|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Studer Pouch orthotopic urinary diversion
T-Pouch orthotopic urinary diversion
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).
time frame: 3 years after date of last patient enrolled
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.
time frame: Within 30 days after surgery
An additional secondary endpoint is cancer recurrence and overall survival, which will be recorded in each patient.
time frame: Yearly for the first 5 years, then every 2 years
Male or female participants at least 18 years old.
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.
|Official title||A Randomized Comparison of the Studer Pouch vs. the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients|
|Principal investigator||Siamak Daneshmand, MD|
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