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

• Sponsor: Intermountain Health Care, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01143259
• Collaborator: Cubist Pharmaceuticals LLC (Industry)
• Enrollment: 274
• Locations: 9
• Arms: 2
• Duration (Months): 27
• Patients Per Site: 30.4
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

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 Names: Entereg

Outcome Measures

Primary Outcome Measures

1. 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

1. Hospital Cost [Upon discharge]

   Total Cost of hospital stay inflation adjusted to 2010 dollars.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	American Fork Hospital	American Fork	Utah	United States	84003
2	Valley View Hospital	Cedar City	Utah	United States	84721
3	Logan Regional Hospital	Logan	Utah	United States	84341
4	Intermoutain Medical Center	Murray	Utah	United States	84157
5	McKay-Dee Hospital	Ogden	Utah	United States	84403
6	Utah Valley	Provo	Utah	United States	84604
7	LDS Hospital	Salt Lake City	Utah	United States	84103
8	Alta View Hospital	Sandy	Utah	United States	84094
9	Dixie Regional	St. George	Utah	United States	84790

Sponsors and Collaborators

• Intermountain Health Care, Inc.
• Cubist Pharmaceuticals LLC

Investigators

• Principal Investigator: Bob Moesinger, MD, Intermountain Health Care, Inc.
• Study Director: Matthew Peters, RN, Intermountain Health Care, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Intermountain Health Care, Inc.
• ClinicalTrials.gov Identifier: NCT01143259
• Other Study ID Numbers: Intermountain Alvimopan1017978
• First Posted: Jun 14, 2010
• Last Update Posted: Sep 4, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Intermountain Health Care, Inc.: Ileus; Post operative ileus
• Additional relevant MeSH terms: Ileus; Alvimopan

Study Results

Participant Flow

Recruitment Details	Date of first enrollment5-24-2010 Date of last enrollment 6-13-2012 Patients were identified in surgeons office and then screen by study coordinators for eligibility.
Pre-assignment Detail	Most common exclusion were patients with history of opioid us > 3 doses in 7 days prior to surgery.

Arm/Group Title	300 mg Polyethylene	Alvimopan
Arm/Group Description	Control Group : 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.	Treatment Group : 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.
Period Title: Overall Study
STARTED	136	138
COMPLETED	113	118
NOT COMPLETED	23	20

Baseline Characteristics

Arm/Group Title	300 mg Polyethylene	Alvimopan	Total
Arm/Group Description	Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.	Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 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.	Total of all reporting groups
Overall Participants	136	138	274
Age, Customized (years) [Mean (Full Range) ]
Age	61	61	61
Sex: Female, Male (Count of Participants)
Female	66 48.5%	69 50%	135 49.3%
Male	70 51.5%	69 50%	139 50.7%
Region of Enrollment (participants) [Number]
United States	136 100%	138 100%	274 100%
Mean BMI (Kg/M^2) [Median (Full Range) ]
Median (Full Range) [Kg/M^2]	28	29	28
Total Cases Using An Open Approach (Cases) [Number]
Number [Cases]	43	25	68

Outcome Measures

1. Primary Outcome

Title	Measure of Improvement Over the Standard
Description	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.
Time Frame	Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day]

Outcome Measure Data

Analysis Population Description

The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.

Arm/Group Title	300 mg Polyethylene	Alvimopan
Arm/Group Description	Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.	Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 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.
Measure Participants	125	123
Mean (Full Range) [Days in the hospital]	4.97	3.98

2. Secondary Outcome

Title	Hospital Cost
Description	Total Cost of hospital stay inflation adjusted to 2010 dollars.
Time Frame	Upon discharge

Outcome Measure Data

Analysis Population Description

The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.

Arm/Group Title	300 mg Polyethylene	Alvimopan
Arm/Group Description	Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.	Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 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.
Measure Participants	125	123
Mean (Full Range) [Dollars]	14,520	12,834

Adverse Events

Time Frame	30 Days after hospital discharge
Arm/Group Title	300 mg Polyethylene		Alvimopan
Arm/Group Description	Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.		Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
All Cause Mortality
	300 mg Polyethylene		Alvimopan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	300 mg Polyethylene		Alvimopan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/136 (0%)		0/138 (0%)
Other (Not Including Serious) Adverse Events
	300 mg Polyethylene		Alvimopan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/136 (9.6%)		3/138 (2.2%)
Gastrointestinal disorders
Post Operative Ileus	13/136 (9.6%)	13	3/138 (2.2%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.