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RECRUITING
NCT03216525
PHASE3

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

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2018-10-01

Completion Date

2024-06-01

Last Updated

2023-09-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

Alvimopan

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

DRUG

Placebo

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