N/A
N=7,050
Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Patients Not Receiving Alvimopan in the Premier Perspective Database
Ileus
Bottom Line
View on ClinicalTrials.gov: NCT01150760 ↗Enrolled (actual)
7,050
Serious AEs
—
Results posted
Sep 2010
Primary outcome: Primary: Percentage of Patients Who Died — 0.4; 1.0 Percent of participants — p=0.0007
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Alvimopan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Died |
0.4; 1.0 | 0.0007 sig |
| PRIMARY Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity |
29.8; 35.7 | < 0.0001 sig |
| PRIMARY Percentage of Patients With In-hospital Cardiovascular Morbidity |
19.4; 24.0 | 0.0001 sig |
| PRIMARY Percentage of Patients With In-hospital Cerebrovascular Morbidity |
0.2; 0.5 | 0.1022 |
| PRIMARY Percentage of Patients With In-hospital Pulmonary Morbidity |
7.3; 10.5 | < 0.0001 sig |
| PRIMARY Percentage of Patients With In-hospital Infection Morbidity |
9.2; 11.5 | 0.0012 sig |
| PRIMARY Percentage of Patients With In-hospital Thromboembolic Morbidity |
1.2; 2.1 | 0.0030 sig |
| PRIMARY Percentage of Patients With In-hospital Other Morbidity |
0.6; 0.7 | 0.7637 |
| PRIMARY Percentage of Patients Who Were Readmitted Within 15 Days of Discharge |
7.4; 8.7 | 0.0402 sig |
| PRIMARY Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge |
1.9; 2.5 | 0.0755 |
| PRIMARY Percentage of Patients Who Were Readmitted Within 30 Days of Discharge |
9.3; 11.2 | 0.0532 |
| PRIMARY Percentage of Patients Discharged to Various Locations |
7.9; 13.8; 87.5; 80.7 | < 0.0001 sig |
| PRIMARY Intensive Care Unit Length of Stay |
0.3; 0.6 | < 0.0001 sig |
| SECONDARY Postoperative Length of Hospital Stay |
5.3; 6.4 | < 0.0001 sig |
Summary
Alvimopan is the first and currently the only FDA-approved therapy for acceleration of the time to upper and lower gastrointestinal (GI) recovery following partial large or small bowel resection surgery with primary anastomosis.
The primary objective of this retrospective observational trial is to assess postoperative morbidity and mortality as reported during the index hospitalization for bowel resection and 15/30-day readmissions of alvimopan vs. non-alvimopan matched patients in the combined Premier/Care Science database(a large medical claims database).
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years at discharge
- Medical claim with an ICD-9-CM procedure code for a primary procedure (identified at position 1 or 2 involving large or small segmental bowel resection with primary anastomosis
- Discharged within the study dates
- Surgery at a participating Premier/Care Sciences hospital
Exclusion Criteria
- Had a diverting ostomy without a primary anastomosis during the index hospitalization
- Had a trauma diagnosis
- Had bowel resections performed on more than 1 day during index hospitalization (this includes cases where a bowel resection and intestinal anastomosis were performed on different days during the index hospitalization)
- Had an excluded non-bowel resection surgical code (i.e., code for a major non-BR surgical procedure [eg., nephroureterectomy, total joint replacement] in position 1 or 2
Data sourced from ClinicalTrials.gov (NCT01150760). 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.