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

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

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.

Study Overview

• Status: Completed
• Conditions: Ileus
• Intervention / Treatment: Drug: 300 mg Polyethylene; Drug: Alvimopam

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.

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • American Fork, Utah, United States, 84003
      • American Fork Hospital
    • Cedar City, Utah, United States, 84721
      • Valley View Hospital
    • Logan, Utah, United States, 84341
      • Logan Regional Hospital
    • Murray, Utah, United States, 84157
      • Intermoutain Medical Center
    • Ogden, Utah, United States, 84403
      • McKay-Dee Hospital
    • Provo, Utah, United States, 84604
      • Utah Valley
    • Salt Lake City, Utah, United States, 84103
      • LDS Hospital
    • Sandy, Utah, United States, 84094
      • Alta View Hospital
    • St. George, Utah, United States, 84790
      • Dixie Regional

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 300 mg Polyethylene	Drug: 300 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.
Active Comparator: Alvimopan	Drug: Alvimopam; 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.; Other Names: Entereg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: Cubist Pharmaceuticals LLC
• Investigators: Principal Investigator: Bob Moesinger, MD, Intermountain Health Care, Inc.; Study Director: Matthew Peters, RN, Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: May 24, 2010
• First Submitted That Met QC Criteria: June 11, 2010
• First Posted (Estimate): June 14, 2010

Study Record Updates

• Last Update Posted (Estimate): September 4, 2014
• Last Update Submitted That Met QC Criteria: August 25, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Post operative ileus; Ileus
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus; Gastrointestinal Agents; Alvimopan
• Other Study ID Numbers: Intermountain Alvimopan1017978