Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Patients Not Receiving Alvimopan in the Premier Perspective Database

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Collaborator: GlaxoSmithKline
• Treatments: Alvimopan

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