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Trial record 2 of 2 for:    22388106 [PUBMED-IDS]

Alvimopan as Rescue in Post op Ileus

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ClinicalTrials.gov Identifier: NCT02742181
Recruitment Status : Unknown
Verified April 2016 by Sharon Stein, University Hospitals Cleveland Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 18, 2016
Last Update Posted : April 18, 2016
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sharon Stein, University Hospitals Cleveland Medical Center

Brief 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


Condition or disease Intervention/treatment Phase
Colorectal Surgery Ileus Drug: Alvimopan Other: Control Group Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Control Trial of The Effectiveness of Entereg as a Rescue Treatment of Postoperative Ileus Following Colorectal Surgery
Study Start Date : May 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Alvimopan

Arm Intervention/treatment
Experimental: Alvimopan group
In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Drug: Alvimopan
Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
Other Name: Entereg

Control Group
Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.
Other: Control Group
Standard postoperative care




Primary Outcome Measures :
  1. Hospital length of stay [ Time Frame: up to 30 days ]
    Date of surgery until discharge


Secondary Outcome Measures :
  1. Time to return of bowel function [ Time Frame: 30 days ]
    Date ileus identified to time of passing flatus, stool and tolerating diet

  2. Complications [ Time Frame: 30 days ]
    All adverse events

  3. Number of reoperations [ Time Frame: 30 days ]
    Any reoperations within 30 days of surgery

  4. Number of Readmissions [ Time Frame: 30 days ]
    Any readmissions within 30 days of surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742181


Contacts
Contact: Bridget Ermlich, RN, MSN 216-844-3602 bridget.ermlich@uhhospitals.org

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Sharon Stein
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Sharon Stein, MD University Hospitals Cleveland Medical Center

Publications:

Responsible Party: Sharon Stein, Staff Surgeon, Associate Professor of Surgery, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02742181     History of Changes
Other Study ID Numbers: 10-15-28
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Alvimopan
Gastrointestinal Agents