Alvimopan as a Rescue Treatment of Postoperative Ileus

Launched by SCOTT STEELE · May 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Alvimopan to see if it can help patients who have had surgery on their intestines and are experiencing a problem called postoperative ileus (POI), which is when the bowel doesn’t function properly after surgery. The trial aims to find out if using Alvimopan can help patients recover faster and shorten their hospital stay. To participate, patients must be 18 years or older, have had specific types of intestinal surgery, and then develop symptoms of POI, like bloating or the inability to pass gas or stool.

Participants in the study will be randomly assigned to either receive Alvimopan or standard care. If they are in the Alvimopan group, they will take up to three doses of the medication to help restore bowel function. The trial is currently recruiting patients, and it’s important to know that there are certain health conditions that may prevent someone from participating, such as severe liver problems or being pregnant. Overall, this study could provide valuable information about the effectiveness and safety of Alvimopan for patients recovering from intestinal surgery.

Gender

ALL

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