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

Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150760
• Other study ID #: Premier clinical outcomes
• Status: Completed
• Phase: N/A
• First received: June 23, 2010
• Last updated: July 16, 2015
• Start date: April 2010
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7050
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ileus

Intervention

Drug:
• Alvimopan
At least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection

Locations

Country	Name	City	State
United States	Premier database	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Who Died	All-cause	Participants were followed up until their hospital discharge after bowel resection	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Percentage of Patients Who Were Readmitted Within 15 Days of Discharge		Within 15 days of discharge from hospitalization for bowel resection	No
Primary	Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge		Between 16-30 days after hospital discharge after bowel resection	No
Primary	Percentage of Patients Who Were Readmitted Within 30 Days of Discharge		Between 0-30 days after hospital discharge after bowel resection	No
Primary	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	No
Primary	Intensive Care Unit Length of Stay		Participants were followed up until their hospital discharge after bowel resection	No
Secondary	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	No