Entereg (Alvimopan) is a peripherally acting mu-opioid receptor antagonist that has been
shown to increase postoperative bowel function in patients after open bowel resection
surgery. It has been proven safe and effective for short-term in-house treatment. At the
present there are several Drug Use Utilization Evaluation studies reporting results involving
the use of alvimopan (ENTEREG) in laparoscopic bowel resection patients. However, this study
will be the first randomized, prospective, double-blind, placebo-controlled trial looking at
this population. We propose that Entereg will decrease the length of stay by one day in the
laparoscopic colon resection patient. We wish to perform a voluntary, double-blinded, placebo
controlled study. We plan an enrollment population of 250 patients. Twelve milligrams of
Entereg will be administered 30 minutes to 5 hours pre-op followed by 12 mg BID, up to 7 days
or 15 total doses. The primary endpoint of the study will be length of stay. The time of GI-2
recovery (toleration of solid food and first bowel movement) and time to GI-3 recovery
(toleration of solid food, and flatus or bowel movement) will be secondary endpoints.
Estimated Enrollment = 250, Study Start Date: November 2010, Estimated Study Completion Date:
May 2012, Estimated Primary Completion Date: Nov 2011.