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

Information source: Intermountain Health Care, Inc.
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ileus

Intervention: Treatment Group (Drug); Control Group (Drug)

Phase: N/A

Status: Recruiting

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.

Overall contact:
Matthew S Peters, RN MS, Phone: 801-442-3703, Email: matthew.peters@imail.org

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: Time to achieve both upper and lower GI recovery

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 (GI) tract but does not compromise central nervous system-mediated opioid-based analgesia. Length of stay (LOS) is an important surrogate measure of quality after colon surgery and the most common reason for prolonged LOS after abdominal surgery is delayed GI recovery (postoperative ileus).

The Food and Drug Administration (FDA) has approved alvimopan (dosed preoperatively and twice daily postoperatively for up to 15 in-hospital doses) for the acceleration of upper and lower GI 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 (MDCS) care process model that is used by Intermountain Healthcare. In the most recently completed alvimopan phase III trial, the mean postoperative LOS was 5. 2 days whereas the mean LOS at Intermountain Healthcare is 4. 4 days without the addition of alvimopan to the MDCS care process model.

This trial will investigate if the addition of alvimopan to the Intermountain Healthcare MDCS care process can decrease LOS compared with the MDCS 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 GFR 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

Matthew S Peters, RN MS, Phone: 801-442-3703, Email: matthew.peters@imail.org

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

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

Logan Regional Hospital, Logan, Utah 84341, United States; Recruiting

Intermoutain Medical Center, Murray, Utah 84157, United States; Recruiting

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

Utah Valley, Provo, Utah 84604, United States; Recruiting

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

Alta View Hospital, Sandy, Utah 84094, United States; Recruiting

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

Additional Information

Starting date: May 2010
Last updated: October 6, 2011

Page last updated: December 08, 2011

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