Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double Blind, Placebo Controlled Study to Study Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use

Conditions
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Ileus

Intervention / Treatment
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* Drug: Alvimopam
* Drug: 300 mg Polyethylene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 Patient scheduled to receive opioid-based postoperative pain management ≥ 48 hrs Elective colon/rectal resection with anastomosis as primary procedure Patient enrolled in multidisciplinary colon care process Exclusion Criteria: Pregnancy or lactation Chronic opioid use or > 3 doses in 7 days prior to surgery History of multiple previous abdominal operations, gastrectomy, bariatric surgery, short bowel syndrome Complete bowel obstruction 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. Patients with severe hepatic impairment (Childs-Pugh class C) ASA 4 or 5 (ASA 4 s incapacitating systemic disease that is a constant threat to life) Non-English speaking patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 300 mg Polyethylene<br> | Drug: 300 mg Polyethylene<br>* 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.<br>|
| Active Comparator: Alvimopan<br> | Drug: Alvimopam<br>* 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.<br>* Other names: Entereg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Cost | Total Cost of hospital stay inflation adjusted to 2010 dollars. | Upon discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ileus, Post operative ileus