Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use
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|ClinicalTrials.gov Identifier: NCT01143259|
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : May 19, 2014
Last Update Posted : September 4, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Ileus||Drug: Alvimopam Drug: 300 mg Polyethylene||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||274 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|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||
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
- 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.
- Hospital Cost [ Time Frame: Upon discharge ]Total Cost of hospital stay inflation adjusted to 2010 dollars.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age > 18
- Patient scheduled to receive opioid-based postoperative pain management ≥ 48 hrs
- Elective colon/rectal resection with anastomosis as primary procedure
- Patient enrolled in multidisciplinary colon care process
- Pregnancy or lactation
- Chronic opioid use or > 3 doses in 7 days prior to surgery
- History of multiple previous abdominal operations, gastrectomy, bariatric surgery, short bowel syndrome
- Complete bowel obstruction
- 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.
- Patients with severe hepatic impairment (Childs-Pugh class C)
- ASA 4 or 5 (ASA 4 s incapacitating systemic disease that is a constant threat to life)
- Non-English speaking patients
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
|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|
|Ogden, Utah, United States, 84403|
|Provo, Utah, United States, 84604|
|Salt Lake City, Utah, United States, 84103|
|Alta View Hospital|
|Sandy, Utah, United States, 84094|
|St. George, Utah, United States, 84790|
|Principal Investigator:||Bob Moesinger, MD||Intermountain Health Care, Inc.|
|Study Director:||Matthew Peters, RN||Intermountain Health Care, Inc.|
|Responsible Party:||Intermountain Health Care, Inc.|
|Other Study ID Numbers:||
|First Posted:||June 14, 2010 Key Record Dates|
|Results First Posted:||May 19, 2014|
|Last Update Posted:||September 4, 2014|
|Last Verified:||April 2014|
Post operative ileus
Digestive System Diseases