Alvimopan as a Rescue Treatment of Postoperative Ileus
Ileus, Gastrointestinal Dysfunction
About this trial
This is an interventional treatment trial for Ileus
Eligibility 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:
a. Patients with symptoms of bloating with or without nausea and vomiting, with absence of passage of flatus or stool who require either
i. Return to NPO status after initial diet attempts
ii. Undergo placement of a nasogastric tube
b. Patients with absence of passage of flatus or stool who are either
i. More than 5 days after open surgery without recovery of GI function
ii. More than 3 days after laparoscopic surgery or ileostomy closure without recovery of GI function
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 Alvimopan 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 have undergone imaging suggesting a small bowel obstruction.
7. Subjects with a medical condition that may interfere with the use of the study medication Alvimopan.
8. Subjects who have a condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study
Sites / Locations
- Cleveland ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Alvimopan Group
Control Group
Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function. 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.
Control patients will follow a standard ERAS pathway after surgery, including NPO status, IV fluid rehydration, and nasogastric decompression, early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.