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

Study Overview
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Brief Summary
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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).

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

Conditions
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Ileus

Intervention / Treatment
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* Drug: Alvimopan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alvimopan Users<br> | Drug: Alvimopan<br>* At least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection<br>* Other names: Entereg;|
| Matched controls<br> | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GI recovery after bowel resection, morbidity after bowel resection, mortality, readmission, length of stay