Overview

Alvimopan as Rescue in Post op Ileus

Status:
Unknown status
Trial end date:
2018-04-01
Target enrollment:
Participant gender:
Summary
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
Phase:
Phase 3
Details
Lead Sponsor:
Sharon Stein
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Alvimopan