Ileus
Conditions
Keywords
Ileus, Post operative ileus
Brief summary
The purpose of this study is to determine if the addition of alvimopan to our care process model for colon resection patients will decrease length of stay. The care process model is a combination of optimal IV fluid management, early feeding, early ambulation, patient education, and pain management.
Detailed description
Narcotic pain medicines bind mu-opioid receptors in the bowel and delay the return of normal function. Alvimopan is a peripherally acting mu-opioid receptor antagonist that blocks mu-opioid receptors in the gastrointestinal tract but does not compromise central nervous system-mediated opioid-based analgesia. Length of stay is an important surrogate measure of quality after colon surgery and the most common reason for prolonged Length of Stay after abdominal surgery is delayed gastrointestinal recovery (postoperative ileus). The Food and Drug Administration has approved alvimopan (dosed preoperatively and twice daily postoperatively for up to 15 in-hospital doses) for the acceleration of upper and lower gastrointestinal recovery after partial bowel resection with primary anastomosis. In the 5 phase III alvimopan efficacy trials, a simple standardized accelerated postoperative care pathway was used rather than a comprehensive, multidisciplinary colon surgery care process model that is used by Intermountain Healthcare. In the most recently completed alvimopan phase III trial, the mean postoperative length of stay was 5.2 days whereas the mean length of stay at Intermountain Healthcare is 4.4 days without the addition of alvimopan to the multidisciplinary colon care process model. This trial will investigate if the addition of alvimopan to the Intermountain Healthcare multidisciplinary care process can decrease length of stay compared with the multidisciplinary care process plus placebo.
Interventions
DRUGAlvimopam
The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
DRUG300 mg Polyethylene
The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
Sponsors
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 2. Patient scheduled to receive opioid-based postoperative pain management ≥ 48 hrs 3. Elective colon/rectal resection with anastomosis as primary procedure 4. Patient enrolled in multidisciplinary colon care process
Exclusion criteria
1. Pregnancy or lactation 2. Chronic opioid use or \> 3 doses in 7 days prior to surgery 3. History of multiple previous abdominal operations, gastrectomy, bariatric surgery, short bowel syndrome 4. Complete bowel obstruction 5. Patients with end-stage renal disease as defined by the need for dialysis and the commonly accepted threshold for dialysis is a Glomerular Filtration Rate of \< 15. 6. Patients with severe hepatic impairment (Childs-Pugh class C) 7. ASA 4 or 5 (ASA 4 s incapacitating systemic disease that is a constant threat to life) 8. Non-English speaking patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Improvement Over the Standard | Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day] | Determine if alvimopan addition to the multidisciplinary care process will result in decreased length of stay compared with the multidisciplinary care process plus placebo. Length of stay is determined by how many days a patient stays in the hospital. This is calculated by subtracting the discharge date from the admit date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Cost | Upon discharge | Total Cost of hospital stay inflation adjusted to 2010 dollars. |
Countries
United States
Participant flow
Recruitment details
Date of first enrollment5-24-2010 Date of last enrollment 6-13-2012 Patients were identified in surgeons office and then screen by study coordinators for eligibility.
Pre-assignment details
Most common exclusion were patients with history of opioid us \> 3 doses in 7 days prior to surgery.
Participants by arm
| Arm | Count |
|---|---|
| 300 mg Polyethylene Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery. | 136 |
| Alvimopan Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days. | 138 |
| Total | 274 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 13 | 9 |
| Overall Study | Screen Failure | 7 | 9 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | 300 mg Polyethylene | Alvimopan | Total |
|---|---|---|---|
| Age, Customized Age | 61 years | 61 years | 61 years |
| Mean BMI | 28 Kg/M^2 | 29 Kg/M^2 | 28 Kg/M^2 |
| Region of Enrollment United States | 136 participants | 138 participants | 274 participants |
| Sex: Female, Male Female | 66 Participants | 69 Participants | 135 Participants |
| Sex: Female, Male Male | 70 Participants | 69 Participants | 139 Participants |
| Total Cases Using An Open Approach | 43 Cases | 25 Cases | 68 Cases |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 136 | 3 / 138 |
| serious Total, serious adverse events | 0 / 136 | 0 / 138 |
Outcome results
Primary
Measure of Improvement Over the Standard
Determine if alvimopan addition to the multidisciplinary care process will result in decreased length of stay compared with the multidisciplinary care process plus placebo. Length of stay is determined by how many days a patient stays in the hospital. This is calculated by subtracting the discharge date from the admit date.
Time frame: Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day]
Population: The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 300 mg Polyethylene | Measure of Improvement Over the Standard | 4.97 Days in the hospital |
| Alvimopan | Measure of Improvement Over the Standard | 3.98 Days in the hospital |
Secondary
Hospital Cost
Total Cost of hospital stay inflation adjusted to 2010 dollars.
Time frame: Upon discharge
Population: The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 300 mg Polyethylene | Hospital Cost | 14,520 Dollars |
| Alvimopan | Hospital Cost | 12,834 Dollars |