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Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01143259
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : May 19, 2014
Last Update Posted : September 4, 2014
Sponsor:
Collaborator:
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

Study Description
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Brief Summary:
The purpose of this study is to determine if the addition of alvimopan to our care process model for colon resection patients will decrease length of stay. The care process model is a combination of optimal IV fluid management, early feeding, early ambulation, patient education, and pain management.

Condition or disease Intervention/treatment Phase
Ileus Drug: Alvimopam Drug: 300 mg Polyethylene Not Applicable

Detailed Description:

Narcotic pain medicines bind mu-opioid receptors in the bowel and delay the return of normal function. Alvimopan is a peripherally acting mu-opioid receptor antagonist that blocks mu-opioid receptors in the gastrointestinal tract but does not compromise central nervous system-mediated opioid-based analgesia. Length of stay is an important surrogate measure of quality after colon surgery and the most common reason for prolonged Length of Stay after abdominal surgery is delayed gastrointestinal recovery (postoperative ileus).

The Food and Drug Administration has approved alvimopan (dosed preoperatively and twice daily postoperatively for up to 15 in-hospital doses) for the acceleration of upper and lower gastrointestinal recovery after partial bowel resection with primary anastomosis. In the 5 phase III alvimopan efficacy trials, a simple standardized accelerated postoperative care pathway was used rather than a comprehensive, multidisciplinary colon surgery care process model that is used by Intermountain Healthcare. In the most recently completed alvimopan phase III trial, the mean postoperative length of stay was 5.2 days whereas the mean length of stay at Intermountain Healthcare is 4.4 days without the addition of alvimopan to the multidisciplinary colon care process model.

This trial will investigate if the addition of alvimopan to the Intermountain Healthcare multidisciplinary care process can decrease length of stay compared with the multidisciplinary care process plus placebo.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled Study to Study Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use
Study Start Date : May 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 300 mg Polyethylene Drug: 300 mg Polyethylene
The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
Active Comparator: Alvimopan Drug: Alvimopam
The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
Other Name: Entereg


Outcome Measures
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Primary Outcome Measures :
  1. Measure of Improvement Over the Standard [ Time Frame: Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day] ]
    Determine if alvimopan addition to the multidisciplinary care process will result in decreased length of stay compared with the multidisciplinary care process plus placebo. Length of stay is determined by how many days a patient stays in the hospital. This is calculated by subtracting the discharge date from the admit date.


Secondary Outcome Measures :
  1. Hospital Cost [ Time Frame: Upon discharge ]
    Total Cost of hospital stay inflation adjusted to 2010 dollars.


Eligibility Criteria
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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. Age > 18
  2. Patient scheduled to receive opioid-based postoperative pain management ≥ 48 hrs
  3. Elective colon/rectal resection with anastomosis as primary procedure
  4. Patient enrolled in multidisciplinary colon care process

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Chronic opioid use or > 3 doses in 7 days prior to surgery
  3. History of multiple previous abdominal operations, gastrectomy, bariatric surgery, short bowel syndrome
  4. Complete bowel obstruction
  5. Patients with end-stage renal disease as defined by the need for dialysis and the commonly accepted threshold for dialysis is a Glomerular Filtration Rate of < 15.
  6. Patients with severe hepatic impairment (Childs-Pugh class C)
  7. ASA 4 or 5 (ASA 4 s incapacitating systemic disease that is a constant threat to life)
  8. Non-English speaking patients
Contacts and Locations
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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): NCT01143259


Locations
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United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Valley View Hospital
Cedar City, Utah, United States, 84721
Logan Regional Hospital
Logan, Utah, United States, 84341
Intermoutain Medical Center
Murray, Utah, United States, 84157
McKay-Dee Hospital
Ogden, Utah, United States, 84403
Utah Valley
Provo, Utah, United States, 84604
LDS Hospital
Salt Lake City, Utah, United States, 84103
Alta View Hospital
Sandy, Utah, United States, 84094
Dixie Regional
St. George, Utah, United States, 84790
Sponsors and Collaborators
Intermountain Health Care, Inc.
Cubist Pharmaceuticals LLC
Investigators
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Principal Investigator: Bob Moesinger, MD Intermountain Health Care, Inc.
Study Director: Matthew Peters, RN Intermountain Health Care, Inc.
More Information
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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01143259    
Other Study ID Numbers: Intermountain Alvimopan1017978
First Posted: June 14, 2010    Key Record Dates
Results First Posted: May 19, 2014
Last Update Posted: September 4, 2014
Last Verified: April 2014
Keywords provided by Intermountain Health Care, Inc.:
Ileus
Post operative ileus
Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Alvimopan
Gastrointestinal Agents