N/A
Completed N=274
Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use
Ileus
Source: ClinicalTrials.gov NCT01143259 ↗
Enrolled (actual)
274
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Measure of Improvement Over the Standard — 4.97; 3.98 Days in the hospital
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure of Improvement Over the Standard |
4.97; 3.98 | — |
| SECONDARY Hospital Cost |
14,520; 12,834 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01143259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.