Trial Outcomes & Findings for Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use (NCT NCT01143259)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

274 participants

Primary outcome timeframe

Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day]

Results posted on

2014-09-04

Participant Flow

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.

Most common exclusion were patients with history of opioid us \> 3 doses in 7 days prior to surgery.

Participant milestones

Participant milestones
Measure	300 mg Polyethylene 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.	Alvimopan 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.
Overall Study STARTED	136	138
Overall Study COMPLETED	113	118
Overall Study NOT COMPLETED	23	20

Reasons for withdrawal

Reasons for withdrawal
Measure	300 mg Polyethylene 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.	Alvimopan 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.
Overall Study Withdrawal by Subject	3	2
Overall Study Protocol Violation	13	9
Overall Study Screen Failure	7	9

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	300 mg Polyethylene n=136 Participants 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.	Alvimopan n=138 Participants 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 n=274 Participants Total of all reporting groups
Age, Customized Age	61 years n=5 Participants	61 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	69 Participants n=7 Participants	135 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	69 Participants n=7 Participants	139 Participants n=5 Participants
Region of Enrollment United States	136 participants n=5 Participants	138 participants n=7 Participants	274 participants n=5 Participants
Mean BMI	28 Kg/M^2 n=5 Participants	29 Kg/M^2 n=7 Participants	28 Kg/M^2 n=5 Participants
Total Cases Using An Open Approach	43 Cases n=5 Participants	25 Cases n=7 Participants	68 Cases n=5 Participants

PRIMARY outcome

Timeframe: Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day]

Population: 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.

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.

Outcome measures

Outcome measures
Measure	300 mg Polyethylene n=125 Participants 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.	Alvimopan n=123 Participants 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 of Improvement Over the Standard	4.97 Days in the hospital Interval 1.9 to 30.2	3.98 Days in the hospital Interval 1.2 to 28.2

SECONDARY outcome

Timeframe: Upon discharge

Population: 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.

Total Cost of hospital stay inflation adjusted to 2010 dollars.

Outcome measures

Outcome measures
Measure	300 mg Polyethylene n=125 Participants 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.	Alvimopan n=123 Participants 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.
Hospital Cost	14,520 Dollars Interval 6170.0 to	12,834 Dollars

Adverse Events

300 mg Polyethylene

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Alvimopan

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	300 mg Polyethylene n=136 participants at risk 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.	Alvimopan n=138 participants at risk 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.
Gastrointestinal disorders Post Operative Ileus	9.6% 13/136 • Number of events 13 • 30 Days after hospital discharge	2.2% 3/138 • Number of events 3 • 30 Days after hospital discharge

Additional Information

Matthew Peters RN MS

Intermountain Healthcare

Phone: 801-442-3703

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place