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

Ileus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143259
• Other study ID #: Intermountain Alvimopan1017978
• Status: Completed
• Phase: N/A
• First received: May 24, 2010
• Last updated: August 25, 2014
• Start date: May 2010
• Est. completion date: August 2012

Study information

• Verified date: April 2014
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ileus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	American Fork Hospital	American Fork	Utah
United States	Valley View Hospital	Cedar City	Utah
United States	Logan Regional Hospital	Logan	Utah
United States	Intermoutain Medical Center	Murray	Utah
United States	McKay-Dee Hospital	Ogden	Utah
United States	Utah Valley	Provo	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	Alta View Hospital	Sandy	Utah
United States	Dixie Regional	St. George	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	Cubist Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Improvement Over the Standard	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.	Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day]	No
Secondary	Hospital Cost	Total Cost of hospital stay inflation adjusted to 2010 dollars.	Upon discharge	No