Alvimopan as a Rescue Treatment of Postoperative Ileus (NCT04405037) | Clinical Trial Compass
CompletedPhase 4
Alvimopan as a Rescue Treatment of Postoperative Ileus
United States65 participantsStarted 2020-08-01
Plain-language summary
This study aims to evaluate the cost effectiveness of Alvimopan as rescue therapy in patients undergoing colorectal or small bowel resection who develop POI, and its safety and effectiveness in reducing LOS and POI duration.
This will be a prospective randomized control trial with a total of 58 patients, 29 in each group. 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 Alvimopan as rescue therapy or to receive conservative standard care.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 medicatio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.