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BRIEF TITLE: Trial of Alvimopan (Entereg) Versus Placebo in Patients Undergoing Radical Cystectomy and Urinary Diversion on an Enhanced Recovery After Surgery ERAS 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


  • Org Study ID: 2017P000330
  • Secondary ID:
  • NCT ID: NCT03216525
  • NCT Alias:
  • Sponsor: Brigham and Women's Hospital - Other
  • Source: Brigham and Women's Hospital

Brief 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.

Detailed Description


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.

Overal Status Start Date Phase Study Type
Recruiting October 1, 2018 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Time to Return of Bowel Function

Primary Outcome 1 - Time Frame: From Day of surgery (Day 0) to Day 30

Condition:

  • Bladder Cancer

Eligibility

Criteria:
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 colectomy, gastrectomy, or gastric bypass, or functional colostomy or
ileostomy

- More than three doses of opioids (oral or parenteral) within 7 days before the day of
surgery

- Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant
chemotherapy allowed.

- Pregnant (identified by a positive serum pregnancy test administered after the initial
screening process and before the commencement of study activities) or lactating, or
not postmenopausal (no menses for at least 1 year) and of childbearing potential and
not using an accepted method of birth control (i.e, surgical sterilization;
intrauterine contraceptive device; oral contraceptive, diaphragm, or condom in
combination with contraceptive cream, jelly, or foam; or abstinence) (Participants
will be asked to use birth control for the entire study and for at least 2 weeks after
the last dose of study drug.)

- Participated in another investigational drug or medical device study within 30 days of
surgery or planning to be enrolled in another investigational drug or medical device
study or any study in which active patient participation was required outside normal
hospital data collection during the course of this study

- Clinically significant laboratory abnormalities at screening that would have resulted
in the cancellation of surgery

- Using illicit drugs or abusing alcohol

- History of previous surgeries, illness, or behavior (eg, depression, psychosis) that
in the opinion of the investigator might have confounded the study results or might
have posed additional risk in administering the study procedures

- Patients with severe dementia (as determined from medical records and history. Severe
dementia will be defined as dementia that impacts daily functioning.)

- Patients with severe hepatic impairment.

- Patients with end-stage renal disease.

- Patients with heart failure. .

- Patients with complete gastrointestinal obstruction.
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Gender: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Official Information

Name: Mark A Preston, MD

Role: Principal Investigator

Affiliation: Brigham and Women's Hospital

Overall Contact

Name: Martin Barylak

Phone: 6175258274

Email: mbarylak@bwh.harvard.edu

Location

Facility Status Contact
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Recruiting Martin Barylak
617-525-8274
mbarylak@bwh.harvard.edu