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 Alvimopan intervention is effective.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
136
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGTime to Return of Bowel Function
To achieve quicker time to return bowel function measured by a composite endpoint of both upper GI recovery (GI-2 recovery = \[first toleration of solid food\] and lower (first bowel movement) gastrointestinal recovery, taking Alvimopan during radical cystectomy, compared to placebo.
Time frame: From Day of surgery (Day 0) to Day 30
Post-operative Length of Stay
Post operative LOS was determined by the difference between the date of hospital discharge and the date of surgery; that is the postoperative LOS for a participant was calculated as follows:(date of discharge)-(date of surgery).
Time frame: Day of surgery (Day 0) to Day of Discharge (Up to Day 30)
Post-operative Morbidity
POM defined as need for nasogastric (NG) tube insertion, hospital stay prolonged because of post-operative ileus (POI) beyond 10 days, or readmission to hospital for POI within 7 days after discharge.
Time frame: During hospitalization up to 7 days after surgery
30 Day Complications
Any Clavien Grade II-V complication.
Time frame: Day of surgery (Day 0) to Day 30
Readmission to Hospital
Any readmission to hospital for \> 24 hours after discharge.
Time frame: Day of Discharge (Up to Day 30)
Open vs Robotic Radical Cystectomy
To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in decreased time to GI2 recovery
Time frame: Day of Surgery (Day 0)
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Cost Analysis
To evaluate costs of surgery and post-operative care between alvimopan and placebo in patients having a radical cystectomy and urinary diversion.
Time frame: Day of surgery (Day 0) to Day 30