The purpose of this study is to look at two standard surgical techniques used during a radical cystectomy and see whether they influence outcomes such as length of stay in the hospital and infections after surgery. This trial will evaluate whether the following surgical methods influence outcomes: A ureteral stent is a thin tube that is placed in the ureter to drain urine from the kidney. Ureteral stents are often used to promote urine drainage after radical cystectomy, but may come at risk of urinary tract infection. Alvimopan is a standard drug used to promote return of bowel function following surgery. Doctors do not know whether alvimopan is beneficial in current clinical practice. The surgeon will decide whether participants will receive a stent and/or alvimopan, but if they are unsure what the best approach is, a surgical technique has been assigned by chance to them.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
530
Surgeon may choose to use a single or double J ureteral stent (6- to 8.5-fr in size) or an alternative ureteral stent of the surgeon's choice.
Patient will receive alvimopan as a fixed 12-mg dose, with the first dose administered 0.5 to 5 h before the start of surgery; administration will be continued with twice daily oral doses postoperatively until hospital discharge or a maximum of 7 days (15 in-hospital doses).
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Suffolk-Commack (Consent Only)
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Nassau (Consent Only)
Rockville Centre, New York, United States
RECRUITINGLength of hospital stay (Alvimopan)
it will define success for the intervention as a length of stay \<6 days (6 days is the current median length of stay).
Time frame: greater than 6 days
Symptomatic urinary tract infections (Stents)
defined as the presence of signs or symptoms indicative of infection (fever, flank or abdominal pain, leukocytosis, radiographic imaging consistent with pyelonephritis) and a positive urine culture (\>100,000 CFU pathogenic bacteria on an appropriately collected urine specimen).
Time frame: within 30 days of surgery
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