Status:
COMPLETED
Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use
Lead Sponsor:
Intermountain Health Care, Inc.
Collaborating Sponsors:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Ileus
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT01143259
Start Date
May 1 2010
End Date
August 1 2012
Last Update
September 4 2014
Active Locations (9)
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1
American Fork Hospital
American Fork, Utah, United States, 84003
2
Valley View Hospital
Cedar City, Utah, United States, 84721
3
Logan Regional Hospital
Logan, Utah, United States, 84341
4
Intermoutain Medical Center
Murray, Utah, United States, 84157