Alvimopan as Rescue in Post op Ileus
Condition: Colorectal Surgery; Ileus
MeSH terms: Ileus
Intervention: Alvimopan; Control Group
Intervention description: Subjects diagnosed with a post operative ileus after surgery will be given alvimopan; Standard postoperative care
Intervention MeSH terms: Alvimopan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This will be a prospective randomized control trial with a total of 142 patients. 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 Entereg as rescue therapy or to
      receive conservative standard care.

      Patients randomized to the Entereg group will be given 12mg of Entereg two times daily from
      the time of randomization until the return of bowel function or 5 days. Both groups will be
      treated with conservative standard care, including bowel rest, reduction in oral diet, and
      placement of nasogastric tube as clinically indicated.

      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.

      Primary outcome will be hospital length of stay. Secondary outcomes will include time to
      return of bowel function, 30-day morbidity/mortality, complications, reoperation and
      readmission.

      Total number of patients: 142 Patients in each study group: 71
    

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:

               -  Return to NPO status after initial diet attempts, or

               -  Placement of nasogastric tube

          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 Entereg 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 were diagnosed with a complete small bowel obstruction preoperatively.

          7. Subjects with a medical condition that may interfere with the use of the study
             medication Entereg.

          8. Subjects who have a condition or general disability or infirmity that in the opinion
             of the investigator precludes further participation in the study