Entereg Laparoscopic Colon Resection Study
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | November 2010 |
| End Date: | July 2015 |
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.
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.
Inclusion Criteria:
Subject is scheduled to undergo laparoscopic (straight or hand assisted) elective colon
resection with primary anastamosis Subject is >18 years of age Subjects can be either male
or female Negative pregnancy test (if patient is a premenopausal female) Medically stable
as determined by the treating surgeon- i.e., subject has an American Society of
Anesthesiologists Physical Status Score of I to III.
Subject understands the study procedures, agrees to participate in the study as per the
study protocol, and has voluntarily provided informed consent Patients who will be
receiving IV Opioid therapy post surgery for pain management.
Exclusion Criteria:
Subject is pregnant or lactating Subject is currently using opioids or has taken more than
3 doses of opioids (oral or parenteral) in the week prior to surgery.
Subject has complete bowel obstruction Subject is not able to understand the informed
consent document or is unable to give informed consent Patients who will receive a
thoracic epidural for pain management post surgery. Subject has any medical instability or
any condition at screening/enrollment which, in the opinion of the investigator, might
confound the results of the study or pose additional risk to the subject during the
administration of study procedures.
We found this trial at
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The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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