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

Comparison of Clinical Outcomes in Bowel Resection Patients Receiving Alvimopan vs. Patients Not Receiving Alvimopan in the Premier Perspective/Care Science Database

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).

Study Overview

• Status: Completed
• Conditions: Ileus
• Intervention / Treatment: Drug: Alvimopan

• Study Type: Observational
• Enrollment (Actual): 7050

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28208
      • Premier database

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Matched controls
Alvimopan Users	Drug: Alvimopan; At least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection; Other Names: Entereg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Who Died	All-cause	Participants were followed up until their hospital discharge after bowel resection
Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity	GI morbidity will be identified using International Classification of Disease 9th Edition Clinical Modification (ICD-9-CM) diagnosis and procedure codes for paralytic ileus, flatulence, eructation, gas pain, insertion of a nasogastric tube, total parenteral nutrition, peripheral parenteral nutrition, digestive symptom complications, diarrhea following GI surgery, intestinal obstruction, abdominal pain, peritoneal adhesions, unspecified protein-calorie malnutrition, parenteral infusion of concentrated nutritional substances, or enteral infusion of concentrated nutritional substances.	Participants were followed up until their hospital discharge after bowel resection
Percentage of Patients With In-hospital Cardiovascular Morbidity	Cardiovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for myocardial infarction; other ischemic events; congestive heart failure and shock; arrhythmias; or other cardiovascular events (cardiac complications, peripheral vascular complications).	Participants were followed up until their hospital discharge after bowel resection
Percentage of Patients With In-hospital Cerebrovascular Morbidity	Cerebrovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for ischemic, thrombotic, embolic or hemorrhagic cerebrovascular accidents; acute but ill-defined cerebrovascular disease; transient cerebral ischemia; syncope; or postoperative cerebrovascular accident.	Participants were followed up until their hospital discharge after bowel resection
Percentage of Patients With In-hospital Pulmonary Morbidity	Pulmonary morbidity was identified using ICD-9-CM diagnosis and procedure codes for pneumonia; infectious pneumonia; respiratory complications, pulmonary collapse; acute respiratory failure or edema; pulmonary congestion and hypostasis; pulmonary/respiratory insufficiency after trauma and/or surgery; dyspnea; or respiratory arrest; transfusion related acute lung injury.	Participants were followed up until their hospital discharge after bowel resection
Percentage of Patients With In-hospital Infection Morbidity	Infection morbidity was identified using ICD-9-CM diagnosis and procedure codes for infection due to central venous catheter; abscess of intestine; peritoneal abscess; sepsis or severe sepsis; infection due to vascular device, implant and graft; urinary tract infection; disruption of internal or external surgical wound; persistent postoperative fistula; or postoperative infection.	Participants were followed up until their hospital discharge after bowel resection
Percentage of Patients With In-hospital Thromboembolic Morbidity	Thromboembolic morbidity was identified using ICD-9-CM diagnosis and procedure codes for pulmonary embolism and infarction; arterial embolism and thrombosis or thrombosis of the lower extremities; vascular disorders of the kidney; acute vascular insufficiency of the intestine; or venous thromboembolism.	Participants were followed up until their hospital discharge after bowel resection
Percentage of Patients With In-hospital Other Morbidity	Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complications not elsewhere classified.	Participants were followed up until their hospital discharge after bowel resection
Percentage of Patients Who Were Readmitted Within 15 Days of Discharge		Within 15 days of discharge from hospitalization for bowel resection
Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge		Between 16-30 days after hospital discharge after bowel resection
Percentage of Patients Who Were Readmitted Within 30 Days of Discharge		Between 0-30 days after hospital discharge after bowel resection
Percentage of Patients Discharged to Various Locations	Location of discharge for patients who were admitted to the hospital for their bowel resection from home	Hospital discharge after bowel resection
Intensive Care Unit Length of Stay		Participants were followed up until their hospital discharge after bowel resection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Length of Hospital Stay	Calendar day of discharge - calendar day of surgery = postoperative length of stay	Measured from the day after bowel resection to the day of hospital discharge

Collaborators and Investigators

• Sponsor: Cubist Pharmaceuticals LLC
• Collaborators: GlaxoSmithKline
• Investigators: Study Director: Lee Techner, DPM, Cubist Pharmaceuticals LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: June 23, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (ESTIMATE): June 25, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 7, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: mortality; length of stay; readmission; GI recovery after bowel resection; morbidity after bowel resection
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Alvimopan
• Other Study ID Numbers: Premier clinical outcomes