NCT01143259

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 19, 2014

Completed
Last Updated

September 4, 2014

Status Verified

April 1, 2014

Enrollment Period

2.1 years

First QC Date

May 24, 2010

Results QC Date

January 7, 2014

Last Update Submit

August 25, 2014

Conditions

Ileus

Keywords

IleusPost operative ileus

Outcome Measures

Primary Outcomes (1)

  • 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]

Secondary Outcomes (1)

  • Hospital Cost

    Upon discharge

Study Arms (2)

300 mg Polyethylene

PLACEBO COMPARATOR
Drug: 300 mg Polyethylene

Alvimopan

ACTIVE COMPARATOR
Drug: Alvimopam

Interventions

AlvimopamDRUG

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.

Also known as: Entereg
Alvimopan
300 mg PolyethyleneDRUG

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.

300 mg Polyethylene

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18
  • Patient scheduled to receive opioid-based postoperative pain management ≥ 48 hrs
  • Elective colon/rectal resection with anastomosis as primary procedure
  • Patient enrolled in multidisciplinary colon care process

You may not qualify if:

  • Pregnancy or lactation
  • Chronic opioid use or \> 3 doses in 7 days prior to surgery
  • History of multiple previous abdominal operations, gastrectomy, bariatric surgery, short bowel syndrome
  • Complete bowel obstruction
  • 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.
  • Patients with severe hepatic impairment (Childs-Pugh class C)
  • ASA 4 or 5 (ASA 4 s incapacitating systemic disease that is a constant threat to life)
  • Non-English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

American Fork Hospital

American Fork, Utah, 84003, United States

Location

Valley View Hospital

Cedar City, Utah, 84721, United States

Location

Logan Regional Hospital

Logan, Utah, 84341, United States

Location

Intermoutain Medical Center

Murray, Utah, 84157, United States

Location

McKay-Dee Hospital

Ogden, Utah, 84403, United States

Location

Utah Valley

Provo, Utah, 84604, United States

Location

LDS Hospital

Salt Lake City, Utah, 84103, United States

Location

Alta View Hospital

Sandy City, Utah, 84094, United States

Location

Dixie Regional

St. George, Utah, 84790, United States

Location

MeSH Terms

Conditions

Ileus

Interventions

alvimopanPolyethylene

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PolyethylenesPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Matthew Peters RN MS
Organization
Intermountain Healthcare
matthew.peters@imail.org
801-442-3703

Study Officials

  • Bob Moesinger, MD

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

  • Matthew Peters, RN

    Intermountain Health Care, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2010

First Posted

June 14, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

September 4, 2014

Results First Posted

May 19, 2014

Record last verified: 2014-04

Locations

US(9)