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
|
