Actively Recruiting
Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol
Led by Brigham and Women's Hospital · Updated on 2023-09-28
136
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing radical cystectomy and urinary diversion via open or robotic approach
- Male or female between 18 and 85 years old
- American Society of Anesthesiologists (ASA) Physical Status Score of class 1 to 4
- Undergoing ileal conduit or ileal neobladder urinary diversion
- Able to understand and agree to the study procedures and voluntarily provide informed consent
You will not qualify if you...
- Scheduled for a partial cystectomy
- Previous total colectomy, gastrectomy, gastric bypass, or having a functional colostomy or ileostomy
- More than three doses of opioids within 7 days before surgery
- Chemotherapy for bladder cancer within 1 month before surgery (prior neoadjuvant chemotherapy allowed)
- Pregnant, lactating, or of childbearing potential without using accepted birth control methods
- Participation in another investigational drug or device study within 30 days before surgery or planning such participation during this study
- Clinically significant lab abnormalities at screening that would cancel surgery
- Using illicit drugs or abusing alcohol
- History of surgeries, illnesses, or behaviors that might affect study results or increase risk
- Severe dementia impacting daily functioning
- Severe liver impairment
- End-stage kidney disease
- Heart failure
- Complete gastrointestinal obstruction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
M
Martin Barylak
CONTACT
A
Anjali Vasavada
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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