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

Information source: Intermountain Health Care, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ileus

Intervention: Alvimopam (Drug); 300 mg Polyethylene (Drug)

Phase: N/A

Status: Completed

Sponsored by: Intermountain Health Care, Inc.

Official(s) and/or principal investigator(s):
Bob Moesinger, MD, Principal Investigator, Affiliation: Intermountain Health Care, Inc.
Matthew Peters, RN, Study Director, Affiliation: Intermountain Health Care, Inc.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Measure of Improvement Over the Standard

Secondary outcome: Hospital Cost

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

American Fork Hospital, American Fork, Utah 84003, United States

Valley View Hospital, Cedar City, Utah 84721, United States

Logan Regional Hospital, Logan, Utah 84341, United States

Intermoutain Medical Center, Murray, Utah 84157, United States

McKay-Dee Hospital, Ogden, Utah 84403, United States

Utah Valley, Provo, Utah 84604, United States

LDS Hospital, Salt Lake City, Utah 84103, United States

Alta View Hospital, Sandy, Utah 84094, United States

Dixie Regional, St. George, Utah 84790, United States

Additional Information

Starting date: May 2010
Last updated: August 25, 2014

Page last updated: August 20, 2015

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