Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Patients Not Receiving Alvimopan in the Premier Perspective Database
Completed
Conditions studied: Ileus
In brief
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).
Key facts
- Study ID
- NCT01150760
- Run by
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- People needed
- 7050
- Starts
- 2010-04-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2015-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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
Where it is running
- Premier database — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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