Brigham and Women's Hospital
To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in quicker return of bowel function (GI-2 recovery = time to upper \[first toleration of solid food\] and lower \[first bowel movement\] gastrointestinal recovery) compared to placebo.
A prospective, randomized, single-center double blind trial of Alvimopan versus placebo for improving patient outcomes and cost during radical cystectomy and urinary diversion will be performed. A randomized trial is necessary to control for all the known and unknown confounders associated with instituting this novel intervention into a surgical procedure. We will recruit 136 subjects (63 patients in each arm of the study per sample size calculation below, plus additional 10 subjects to account for drop outs). A control group will be administered a placebo in order to directly compare if the A…
Inclusion Criteria: * Patients undergoing radical cystectomy and urinary diversion via open or robotic approach. * Man or woman between the ages of 18 and 85. * American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4 * Ileal conduit or ileal neobladder urinary diversion * Able to understand the study procedures, agreed to participate in the study program, and voluntarily provided informed consent Exclusion criteria: * Patients who met any of the following criteria were excluded from participating in the study: * Scheduled for a partial cystectomy * Previous total cole…
To determine if Alvimopan during radical cystectomy with urinary diversion results in faster return of bowel function.
To determine if placebo during radical cystectomy with urinary diversion results in faster return of bowel function.
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