An observational study in Ileus, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-07.
Sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Observational
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).
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the lead sponsor of 65 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Retrospective cohort study using the medical claims Premier/Care Science database. The study time frame was from January 1, 2009 through December 31, 2009.
Exclusion Criteria:
Drug: Alvimopan
At least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection
Also known as: Entereg
Percentage of Patients Who Died
All-cause
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Participants were followed up until their hospital discharge after bowel resection
Percentage of Patients Who Were Readmitted Within 15 Days of Discharge
Time frame: Within 15 days of discharge from hospitalization for bowel resection
Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge
Time frame: Between 16-30 days after hospital discharge after bowel resection
Percentage of Patients Who Were Readmitted Within 30 Days of Discharge
Time frame: 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
Time frame: Hospital discharge after bowel resection
Intensive Care Unit Length of Stay
Time frame: Participants were followed up until their hospital discharge after bowel resection
Postoperative Length of Hospital Stay
Calendar day of discharge - calendar day of surgery = postoperative length of stay
Time frame: Measured from the day after bowel resection to the day of hospital discharge
| Milestone | Alvimopan Users | Matched Controls |
|---|---|---|
| Started | 3525 | 3525 |
| Completed | 3525 | 3525 |
| Not completed | 0 | 0 |
All-cause
| Percent of participants | Alvimopan Users | Matched Controls |
|---|---|---|
| Percentage of Patients Who Died | 0.4 | 1.0 |
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.
| Percent of participants | Alvimopan Users | Matched Controls |
|---|---|---|
| Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity | 29.8 | 35.7 |
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).
| Percent of participants | Alvimopan Users | Matched Controls |
|---|---|---|
| Percentage of Patients With In-hospital Cardiovascular Morbidity | 19.4 | 24.0 |
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.
| Percent of participants | Alvimopan Users | Matched Controls |
|---|---|---|
| Percentage of Patients With In-hospital Cerebrovascular Morbidity | 0.2 | 0.5 |
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.
| Percent of participants | Alvimopan Users | Matched Controls |
|---|---|---|
| Percentage of Patients With In-hospital Pulmonary Morbidity | 7.3 | 10.5 |
Calendar day of discharge - calendar day of surgery = postoperative length of stay
| Days | Alvimopan Users | Matched Controls |
|---|---|---|
| Postoperative Length of Hospital Stay | 5.3 ± 3.1 | 6.4 ± 4.8 |
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.
| Percent of participants | Alvimopan Users | Matched Controls |
|---|---|---|
| Percentage of Patients With In-hospital Infection Morbidity | 9.2 | 11.5 |
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.
| Percent of participants | Alvimopan Users | Matched Controls |
|---|---|---|
| Percentage of Patients With In-hospital Thromboembolic Morbidity | 1.2 | 2.1 |
Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complications not elsewhere classified.
| Percent of participants | Alvimopan Users | Matched Controls |
|---|---|---|
| Percentage of Patients With In-hospital Other Morbidity | 0.6 | 0.7 |
| Percent of partcipants | Alvimopan Users | Matched Controls |
|---|---|---|
| Percentage of Patients Who Were Readmitted Within 15 Days of Discharge | 7.4 | 8.7 |
| Percent of participants | Alvimopan Users | Matched Controls |
|---|---|---|
| Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge | 1.9 | 2.5 |
| Percent of participants | Alvimopan Users | Matched Controls |
|---|---|---|
| Percentage of Patients Who Were Readmitted Within 30 Days of Discharge | 9.3 | 11.2 |
Location of discharge for patients who were admitted to the hospital for their bowel resection from home
| Percent of participants | Alvimopan Users | Matched Controls |
|---|---|---|
| Health care facility | 7.9 | 13.8 |
| Home | 87.5 | 80.7 |
| Days | Alvimopan Users | Matched Controls |
|---|---|---|
| Intensive Care Unit Length of Stay | 0.3 ± 1.4 | 0.6 ± 2.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alvimopan Users | — | — | — |
| Matched Controls | — | — | — |
| Age, Continuous(years) | Alvimopan Users | Matched Controls | Total |
|---|---|---|---|
| Mean | 61.9 ± 14.1 | 61.8 ± 14.7 | 61.9 ± 14.4 |
| Sex: Female, Male(Participants) | Alvimopan Users | Matched Controls | Total |
|---|---|---|---|
| Female | 1847 | 1872 | 3719 |
| Male | 1678 | 1653 | 3331 |
| Race/Ethnicity, Customized(Participants) | Alvimopan Users | Matched Controls | Total |
|---|---|---|---|
| Black or African American | 331 | 368 | 699 |
| White | 2675 | 2543 | 5218 |
| Other | 519 | 614 | 1133 |
| Procedure type(Participants) | Alvimopan Users | Matched Controls | Total |
|---|---|---|---|
| Laparoscopic colon or rectal resection | 1427 | 1427 | 2854 |
| Open colon or rectal resection | 1171 | 1171 | 2342 |
| Laparoscopic or open colon or rectal resection | 424 | 424 | 848 |
| Laparoscopic or open small bowel resection | 181 | 181 | 362 |
| Laparoscopic or open ostomy takedown, bypass,other | 322 | 322 | 644 |
| Surgeon type(Participants) | Alvimopan Users | Matched Controls | Total |
|---|---|---|---|
| General surgeon | 1809 | 1809 | 3618 |
| Colorectal surgeon | 1357 | 1357 | 2714 |
| Other | 359 | 359 | 718 |
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)