Ileus
Conditions
Keywords
GI recovery after bowel resection, morbidity after bowel resection, mortality, readmission, length of stay
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).
Interventions
DRUGAlvimopan
At least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection
Sponsors
GlaxoSmithKline
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensive Care Unit Length of Stay | Participants were followed up until their hospital discharge after bowel resection | — |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | 3,525 |
| Matched Controls Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan | 3,525 |
| Total | 7,050 |
Baseline characteristics
| Characteristic | Total | Alvimopan Users | Matched Controls |
|---|---|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 14.4 | 61.9 years STANDARD_DEVIATION 14.1 | 61.8 years STANDARD_DEVIATION 14.7 |
| Procedure type Laparoscopic colon or rectal resection | 2854 Participants | 1427 Participants | 1427 Participants |
| Procedure type Laparoscopic or open colon or rectal resection | 848 Participants | 424 Participants | 424 Participants |
| Procedure type Laparoscopic or open ostomy takedown, bypass,other | 644 Participants | 322 Participants | 322 Participants |
| Procedure type Laparoscopic or open small bowel resection | 362 Participants | 181 Participants | 181 Participants |
| Procedure type Open colon or rectal resection | 2342 Participants | 1171 Participants | 1171 Participants |
| Race/Ethnicity, Customized Black or African American | 699 Participants | 331 Participants | 368 Participants |
| Race/Ethnicity, Customized Other | 1133 Participants | 519 Participants | 614 Participants |
| Race/Ethnicity, Customized White | 5218 Participants | 2675 Participants | 2543 Participants |
| Sex: Female, Male Female | 3719 Participants | 1847 Participants | 1872 Participants |
| Sex: Female, Male Male | 3331 Participants | 1678 Participants | 1653 Participants |
| Surgeon type Colorectal surgeon | 2714 Participants | 1357 Participants | 1357 Participants |
| Surgeon type General surgeon | 3618 Participants | 1809 Participants | 1809 Participants |
| Surgeon type Other | 718 Participants | 359 Participants | 359 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Intensive Care Unit Length of Stay
Time frame: Participants were followed up until their hospital discharge after bowel resection
Population: Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \[for the alvimopan cohort\] during the patient's hospitalization)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alvimopan Users | Intensive Care Unit Length of Stay | 0.3 Days | Standard Deviation 1.4 |
| Matched Controls | Intensive Care Unit Length of Stay | 0.6 Days | Standard Deviation 2.4 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
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
Time frame: Hospital discharge after bowel resection
Population: Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \[for the alvimopan cohort\] during the patient's hospitalization)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alvimopan Users | Percentage of Patients Discharged to Various Locations | Health care facility | 7.9 Percent of participants |
| Alvimopan Users | Percentage of Patients Discharged to Various Locations | Home | 87.5 Percent of participants |
| Matched Controls | Percentage of Patients Discharged to Various Locations | Health care facility | 13.8 Percent of participants |
| Matched Controls | Percentage of Patients Discharged to Various Locations | Home | 80.7 Percent of participants |
p-value: <0.0001Chi-squared
Primary
Percentage of Patients Who Died
All-cause
Time frame: Participants were followed up until their hospital discharge after bowel resection
Population: Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \[for the alvimopan cohort\] during their hospitalization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alvimopan Users | Percentage of Patients Who Died | 0.4 Percent of participants |
| Matched Controls | Percentage of Patients Who Died | 1.0 Percent of participants |
p-value: 0.0007Chi-squared
Primary
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
Population: Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \[for the alvimopan cohort\] during the patient's hospitalization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alvimopan Users | Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge | 1.9 Percent of participants |
| Matched Controls | Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge | 2.5 Percent of participants |
p-value: 0.0755Chi-squared
Primary
Percentage of Patients Who Were Readmitted Within 15 Days of Discharge
Time frame: Within 15 days of discharge from hospitalization for bowel resection
Population: Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \[for the alvimopan cohort\] during the patient's hospitalization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alvimopan Users | Percentage of Patients Who Were Readmitted Within 15 Days of Discharge | 7.4 Percent of partcipants |
| Matched Controls | Percentage of Patients Who Were Readmitted Within 15 Days of Discharge | 8.7 Percent of partcipants |
p-value: 0.0402Chi-squared
Primary
Percentage of Patients Who Were Readmitted Within 30 Days of Discharge
Time frame: Between 0-30 days after hospital discharge after bowel resection
Population: Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \[for the alvimopan cohort\] during the patient's hospitalization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alvimopan Users | Percentage of Patients Who Were Readmitted Within 30 Days of Discharge | 9.3 Percent of participants |
| Matched Controls | Percentage of Patients Who Were Readmitted Within 30 Days of Discharge | 11.2 Percent of participants |
p-value: 0.0532Chi-squared
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).
Time frame: Participants were followed up until their hospital discharge after bowel resection
Population: Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \[for the alvimopan cohort\] during their hospitalization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alvimopan Users | Percentage of Patients With In-hospital Cardiovascular Morbidity | 19.4 Percent of participants |
| Matched Controls | Percentage of Patients With In-hospital Cardiovascular Morbidity | 24.0 Percent of participants |
p-value: 0.0001Chi-squared
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.
Time frame: Participants were followed up until their hospital discharge after bowel resection
Population: Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \[for the alvimopan cohort\] during their hospitalization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alvimopan Users | Percentage of Patients With In-hospital Cerebrovascular Morbidity | 0.2 Percent of participants |
| Matched Controls | Percentage of Patients With In-hospital Cerebrovascular Morbidity | 0.5 Percent of participants |
p-value: 0.1022Chi-squared
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.
Time frame: Participants were followed up until their hospital discharge after bowel resection
Population: Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \[for the alvimopan cohort\] during their hospitalization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alvimopan Users | Percentage of Patients With In-hospital Infection Morbidity | 9.2 Percent of participants |
| Matched Controls | Percentage of Patients With In-hospital Infection Morbidity | 11.5 Percent of participants |
p-value: 0.0012Chi-squared
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.
Time frame: Participants were followed up until their hospital discharge after bowel resection
Population: Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \[for the alvimopan cohort\] during their hospitalization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alvimopan Users | Percentage of Patients With In-hospital Other Morbidity | 0.6 Percent of participants |
| Matched Controls | Percentage of Patients With In-hospital Other Morbidity | 0.7 Percent of participants |
p-value: 0.7637Chi-squared
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.
Time frame: Participants were followed up until their hospital discharge after bowel resection
Population: Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \[for the alvimopan cohort\] during their hospitalization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alvimopan Users | Percentage of Patients With In-hospital Pulmonary Morbidity | 7.3 Percent of participants |
| Matched Controls | Percentage of Patients With In-hospital Pulmonary Morbidity | 10.5 Percent of participants |
p-value: <0.0001Chi-squared
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.
Time frame: Participants were followed up until their hospital discharge after bowel resection
Population: Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \[for the alvimopan cohort\] during their hospitalization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alvimopan Users | Percentage of Patients With In-hospital Thromboembolic Morbidity | 1.2 Percent of participants |
| Matched Controls | Percentage of Patients With In-hospital Thromboembolic Morbidity | 2.1 Percent of participants |
p-value: 0.003Chi-squared
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.
Time frame: Participants were followed up until their hospital discharge after bowel resection
Population: Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \[for the alvimopan cohort\] during their hospitalization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alvimopan Users | Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity | 29.8 Percent of participants |
| Matched Controls | Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity | 35.7 Percent of participants |
p-value: <0.0001Chi-squared
Secondary
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
Population: Modified intent-to-treat (included patients who met all base population, inclusion and exclusion criteria, received ≥ 3 and ≤ 15 doses of alvimopan \[for alvimopan cohort\] during the patient's hospitalization, and received parenteral opioid on ≥ 1 postoperative day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alvimopan Users | Postoperative Length of Hospital Stay | 5.3 Days | Standard Deviation 3.1 |
| Matched Controls | Postoperative Length of Hospital Stay | 6.4 Days | Standard Deviation 4.8 |
p-value: <0.0001Wilcoxon (Mann-Whitney)