Bladder Cancer
Conditions
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.
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.
Sponsors
Merck Sharp & Dohme LLC
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double blind design.
Intervention model description
This is a prospective, randomized, single-center double blind trial of Alvimopan versus placebo for improving patient outcomes and cost during radical cystectomy and urinary diversion.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Return of Bowel Function | From Day of surgery (Day 0) to Day 30 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Morbidity | During hospitalization up to 7 days after surgery | 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. |
| 30 Day Complications | Day of surgery (Day 0) to Day 30 | Any Clavien Grade II-V complication. |
| Post-operative Length of Stay | Day of surgery (Day 0) to Day of Discharge (Up to Day 30) | 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). |
| Open vs Robotic Radical Cystectomy | Day of Surgery (Day 0) | To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in decreased time to GI2 recovery |
| Cost Analysis | Day of surgery (Day 0) to Day 30 | To evaluate costs of surgery and post-operative care between alvimopan and placebo in patients having a radical cystectomy and urinary diversion. |
| Readmission to Hospital | Day of Discharge (Up to Day 30) | Any readmission to hospital for \> 24 hours after discharge. |
Countries
United States
Contacts
Primary ContactMartin Barylak
Backup ContactAnjali Vasavada
Outcome results
None listed