Ileus Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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