Clinical trial NCT01150760: Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Patients Not Receiving Alvimopan in the Premier Perspective Database
Official title: Comparison of Clinical Outcomes in Bowel Resection Patients Receiving Alvimopan vs. Patients Not Receiving Alvimopan in the Premier Perspective/Care Science Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ileus
Keywords: GI recovery after bowel resection
morbidity after bowel resection
mortality
readmission
length of stay
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2010-06-25
Enrollment: 7050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective cohort study using the medical claims Premier/Care Science database. The study time frame was from January 1, 2009 through December 31, 2009.

Brief 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

Primary outcomes:
measure: Percentage of Patients Who Died
timeFrame: Participants were followed up until their hospital discharge after bowel resection
measure: Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity
timeFrame: Participants were followed up until their hospital discharge after bowel resection
measure: Percentage of Patients With In-hospital Cardiovascular Morbidity
timeFrame: Participants were followed up until their hospital discharge after bowel resection
measure: Percentage of Patients With In-hospital Cerebrovascular Morbidity
timeFrame: Participants were followed up until their hospital discharge after bowel resection
measure: Percentage of Patients With In-hospital Pulmonary Morbidity
timeFrame: Participants were followed up until their hospital discharge after bowel resection
measure: Percentage of Patients With In-hospital Infection Morbidity
timeFrame: Participants were followed up until their hospital discharge after bowel resection
measure: Percentage of Patients With In-hospital Thromboembolic Morbidity
timeFrame: Participants were followed up until their hospital discharge after bowel resection
measure: Percentage of Patients With In-hospital Other Morbidity
timeFrame: Participants were followed up until their hospital discharge after bowel resection
measure: Percentage of Patients Who Were Readmitted Within 15 Days of Discharge
timeFrame: Within 15 days of discharge from hospitalization for bowel resection
measure: Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge
timeFrame: Between 16-30 days after hospital discharge after bowel resection
measure: Percentage of Patients Who Were Readmitted Within 30 Days of Discharge
timeFrame: Between 0-30 days after hospital discharge after bowel resection
measure: Percentage of Patients Discharged to Various Locations
timeFrame: Hospital discharge after bowel resection
measure: Intensive Care Unit Length of Stay
timeFrame: Participants were followed up until their hospital discharge after bowel resection
Secondary outcomes:
measure: Postoperative Length of Hospital Stay
timeFrame: Measured from the day after bowel resection to the day of hospital discharge
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Premier database
state: North Carolina
Study officials:
affiliation: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
name: Lee Techner, DPM
role: STUDY_DIRECTOR
References:
citation: Delaney CP, Craver C, Gibbons MM, Rachfal AW, VandePol CJ, Cook SF, Poston SA, Calloway M, Techner L. Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection. Ann Surg. 2012 Apr;255(4):731-8. doi: 10.1097/SLA.0b013e31824a36cc.