RecruitingPhase 3NCT03216525

Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol

A Randomized, Double-blind, Single-Center Trial of Alvimopan (Entereg) Versus Placebo in Patients Undergoing Radical Cystectomy and Urinary Diversion on an Enhanced Recovery After Surgery ERAS Protocol


Sponsor

Brigham and Women's Hospital

Enrollment

136 participants

Start Date

Oct 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether alvimopan (a drug that helps the bowels start working again after surgery) reduces recovery time for patients having their bladder surgically removed (radical cystectomy) as part of an enhanced recovery program. **You may be eligible if...** - You are between 18 and 85 years old - You are scheduled for a radical cystectomy (bladder removal) with creation of a new urinary passage using part of the bowel (ileal conduit or neobladder) - Your surgery will be performed either as open or robotic - You are in reasonable general health **You may NOT be eligible if...** - You are not having a radical cystectomy - You are having a different type of urinary reconstruction - You have serious conditions that make alvimopan unsafe (such as severe liver disease or prior bowel surgery) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlvimopan

To determine if Alvimopan during radical cystectomy with urinary diversion results in faster return of bowel function.

DRUGPlacebo

To determine if placebo during radical cystectomy with urinary diversion results in faster return of bowel function.


Locations(1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT03216525


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