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

Not Applicable

Completed

• Conditions: Ileus
• Interventions: Drug: Alvimopam; Drug: 300 mg Polyethylene

• Registration Number: NCT01143259
• Lead Sponsor: Intermountain Health Care, Inc.

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.

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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2012-06
• Study Completion: 2012-08
• Results First Submitted: 2014-01-07
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-15
• Results First Posted: 2014-05-19
• Last Update Submitted: 2014-08-25
• Last Update Posted: 2014-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alvimopan	Alvimopam	-
300 mg Polyethylene	300 mg Polyethylene	-

Primary Outcome Measures

Name	Time	Method
Measure of Improvement Over the Standard	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

Name	Time	Method
Hospital Cost	Upon discharge	Total Cost of hospital stay inflation adjusted to 2010 dollars.

Trial Locations

Locations (9)

Logan Regional Hospital; 🇺🇸 Logan, Utah, United States

Alta View Hospital; 🇺🇸 Sandy, Utah, United States

McKay-Dee Hospital; 🇺🇸 Ogden, Utah, United States

LDS Hospital; 🇺🇸 Salt Lake City, Utah, United States

Utah Valley; 🇺🇸 Provo, Utah, United States

Dixie Regional; 🇺🇸 St. George, Utah, United States

American Fork Hospital; 🇺🇸 American Fork, Utah, United States

Valley View Hospital; 🇺🇸 Cedar City, Utah, United States

Intermoutain Medical Center; 🇺🇸 Murray, Utah, United States