Alvimopan as Rescue in Post op Ileus

• Status: Unknown status
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sharon Stein
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Alvimopan

Criteria

Inclusion Criteria:

1. Subjects who have benign or malignant colonic or rectal disease that have undergone laparoscopic or open colorectal resection, small bowel resection or ileostomy reversal with small bowel resection and subsequently developed postoperative ileus, defined as:

• Return to NPO status after initial diet attempts, or

• Placement of nasogastric tube

2. Subjects who are 18 years of age and older

3. Subjects of either gender

4. Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent.

Exclusion Criteria:

1. Subjects who received Entereg preoperatively.

2. Subjects that have taken therapeutic doses of opioids for more than 7 days immediately prior to surgery.

3. Subjects with severe hepatic impairment.

4. Subjects with end-stage renal disease.

5. Subjects who are pregnant.

6. Subjects who were diagnosed with a complete small bowel obstruction preoperatively.

7. Subjects with a medical condition that may interfere with the use of the study medication Entereg.

8. Subjects who have a condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study