COMPLETED

Alvimopan as a Rescue Treatment of Postoperative Ileus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

A Prospective Randomized Control Trial of The Effectiveness of Alvimopan as a Rescue Treatment of Postoperative Ileus Following Colorectal Surgery

Quick Facts

Study Start:2020-08-01

Study Completion:2024-04-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04405037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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.	* 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

Inclusion Criteria

Exclusion 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:
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.

* 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

Contacts and Locations

Principal Investigator

Conor Delaney, MD, PhD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Scott Steele

Conor Delaney, MD, PhD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-01

Study Completion Date2024-04-02

Study Record Updates

Study Start Date2020-08-01

Study Completion Date2024-04-02

Terms related to this study

Additional Relevant MeSH Terms

Ileus
Gastrointestinal Dysfunction