Alvimopan as Rescue in Post op Ileus
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|ClinicalTrials.gov Identifier: NCT02742181|
Recruitment Status : Unknown
Verified April 2016 by Sharon Stein, University Hospitals Cleveland Medical Center.
Recruitment status was: Not yet recruiting
First Posted : April 18, 2016
Last Update Posted : April 18, 2016
This will be a prospective randomized control trial with a total of 142 patients. Patients who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy reversal with small bowel resection that subsequently develop postoperative ileus will be eligible for enrollment. If they meet inclusion/exclusion criteria, they will be randomized at the time of diagnosis of postoperative ileus to receive Entereg as rescue therapy or to receive conservative standard care.
Patients randomized to the Entereg group will be given 12mg of Entereg two times daily from the time of randomization until the return of bowel function or 5 days. Both groups will be treated with conservative standard care, including bowel rest, reduction in oral diet, and placement of nasogastric tube as clinically indicated.
All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Primary outcome will be hospital length of stay. Secondary outcomes will include time to return of bowel function, 30-day morbidity/mortality, complications, reoperation and readmission.
Total number of patients: 142 Patients in each study group: 71
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Surgery Ileus||Drug: Alvimopan Other: Control Group||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Control Trial of The Effectiveness of Entereg as a Rescue Treatment of Postoperative Ileus Following Colorectal Surgery|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
Experimental: Alvimopan group
In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
Other Name: Entereg
Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.
Other: Control Group
Standard postoperative care
- Hospital length of stay [ Time Frame: up to 30 days ]Date of surgery until discharge
- Time to return of bowel function [ Time Frame: 30 days ]Date ileus identified to time of passing flatus, stool and tolerating diet
- Complications [ Time Frame: 30 days ]All adverse events
- Number of reoperations [ Time Frame: 30 days ]Any reoperations within 30 days of surgery
- Number of Readmissions [ Time Frame: 30 days ]Any readmissions within 30 days of surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742181
|Contact: Bridget Ermlich, RN, MSNfirstname.lastname@example.org|
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Sharon Stein, MD||University Hospitals Cleveland Medical Center|