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

Completed

Conditions: Ileus

Interventions: Drug: Alvimopan

Registration Number: NCT01150760

Lead Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 7050

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alvimopan Users	Alvimopan	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Who Died	Participants were followed up until their hospital discharge after bowel resection	All-cause
Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity	Participants were followed up until their hospital discharge after bowel resection	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.
Percentage of Patients With In-hospital Cardiovascular Morbidity	Participants were followed up until their hospital discharge after bowel resection	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).
Percentage of Patients With In-hospital Cerebrovascular Morbidity	Participants were followed up until their hospital discharge after bowel resection	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.
Percentage of Patients With In-hospital Pulmonary Morbidity	Participants were followed up until their hospital discharge after bowel resection	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.
Percentage of Patients With In-hospital Infection Morbidity	Participants were followed up until their hospital discharge after bowel resection	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.
Percentage of Patients With In-hospital Thromboembolic Morbidity	Participants were followed up until their hospital discharge after bowel resection	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.
Percentage of Patients With In-hospital Other Morbidity	Participants were followed up until their hospital discharge after bowel resection	Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complications not elsewhere classified.
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	Hospital discharge after bowel resection	Location of discharge for patients who were admitted to the hospital for their bowel resection from home
Intensive Care Unit Length of Stay	Participants were followed up until their hospital discharge after bowel resection

Secondary Outcome Measures

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