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

NCT01143259 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2014-09-04

Study results available
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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.

Conditions

  • Ileus

Interventions

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.

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.

Sponsors & Collaborators

  • Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    collaborator INDUSTRY

  • Intermountain Health Care, Inc.

    lead OTHER

Principal Investigators

  • Bob Moesinger, MD · Intermountain Health Care, Inc.

  • Matthew Peters, RN · Intermountain Health Care, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-06-30
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01143259 on ClinicalTrials.gov