Status:
COMPLETED
Alvimopan as a Rescue Treatment of Postoperative Ileus
Lead Sponsor:
Scott Steele
Conditions:
Ileus
Gastrointestinal Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 reduci...
Detailed Description
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 reduci...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04405037
Start Date
August 1 2020
End Date
April 2 2024
Last Update
August 20 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195