Clinical trial NCT01143259: Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileus
Keywords: Ileus
Post operative ileus
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
First posted: 2010-06-14
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Measure of Improvement Over the Standard
timeFrame: Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day]
Secondary outcomes:
measure: Hospital Cost
timeFrame: Upon discharge
Other outcomes:
Locations:
city: American Fork
country: United States
facility: American Fork Hospital
state: Utah
city: Cedar City
country: United States
facility: Valley View Hospital
state: Utah
city: Logan
country: United States
facility: Logan Regional Hospital
state: Utah
city: Murray
country: United States
facility: Intermoutain Medical Center
state: Utah
city: Ogden
country: United States
facility: McKay-Dee Hospital
state: Utah
city: Provo
country: United States
facility: Utah Valley
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Sandy
country: United States
facility: Alta View Hospital
state: Utah
city: St. George
country: United States
facility: Dixie Regional
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Bob Moesinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Intermountain Health Care, Inc.
name: Matthew Peters, RN
role: STUDY_DIRECTOR
References: