Overview

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

Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Intermountain Health Care, Inc.
Collaborator:
Cubist Pharmaceuticals LLC
Treatments:
Alvimopan
Criteria
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