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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01150760
First received: June 23, 2010
Last updated: September 8, 2010
Last verified: September 2010
Results First Received: August 17, 2010  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Retrospective
Condition: Ileus
Intervention: Drug: Alvimopan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Participant Flow:   Overall Study
    Alvimopan Users     Matched Controls  
STARTED     3525     3525  
COMPLETED     3525     3525  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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
Total Total of all reporting groups

Baseline Measures
    Alvimopan Users     Matched Controls     Total  
Number of Participants  
[units: participants]
  3525     3525     7050  
Age  
[units: years]
Mean ± Standard Deviation
  61.9  ± 14.1     61.8  ± 14.7     61.9  ± 14.4  
Gender  
[units: participants]
     
Female     1847     1872     3719  
Male     1678     1653     3331  
Race (NIH/OMB)  
[units: Participants]
     
Black or African American     331     368     699  
White     2675     2543     5218  
Other     519     614     1133  
Procedure type [1]
[units: Participants]
     
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 [2]
[units: Participants]
     
General surgeon     1809     1809     3618  
Colorectal surgeon     1357     1357     2714  
Other     359     359     718  
[1] Category of bowel resection that patients underwent during their hospitalization
[2] The type of surgeon that performed the patient's bowel resection during their hospitalization



  Outcome Measures
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1.  Primary:   Percentage of Patients Who Died   [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type Primary
Measure Title Percentage of Patients Who Died
Measure Description All-cause
Time Frame Participants were followed up until their hospital discharge after bowel resection  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  3525     3525  
Percentage of Patients Who Died  
[units: Percent of participants]
  0.4     1.0  


Statistical Analysis 1 for Percentage of Patients Who Died
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.0007
Mean Difference (Net) [4] -0.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



2.  Primary:   Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity   [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type Primary
Measure Title Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity
Measure Description 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  3525     3525  
Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity  
[units: Percent of participants]
  29.8     35.7  


Statistical Analysis 1 for Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity
Groups [1] All groups
Method [2] Chi-squared
P Value [3] < 0.0001
Mean Difference (Net) [4] -5.9
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



3.  Primary:   Percentage of Patients With In-hospital Cardiovascular Morbidity   [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type Primary
Measure Title Percentage of Patients With In-hospital Cardiovascular Morbidity
Measure Description 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  3525     3525  
Percentage of Patients With In-hospital Cardiovascular Morbidity  
[units: Percent of participants]
  19.4     24.0  


Statistical Analysis 1 for Percentage of Patients With In-hospital Cardiovascular Morbidity
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.0001
Mean Difference (Net) [4] -4.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



4.  Primary:   Percentage of Patients With In-hospital Cerebrovascular Morbidity   [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type Primary
Measure Title Percentage of Patients With In-hospital Cerebrovascular Morbidity
Measure Description 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  3525     3525  
Percentage of Patients With In-hospital Cerebrovascular Morbidity  
[units: Percent of participants]
  0.2     0.5  


Statistical Analysis 1 for Percentage of Patients With In-hospital Cerebrovascular Morbidity
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.1022
Mean Difference (Net) [4] -0.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



5.  Primary:   Percentage of Patients With In-hospital Pulmonary Morbidity   [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type Primary
Measure Title Percentage of Patients With In-hospital Pulmonary Morbidity
Measure Description 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  3525     3525  
Percentage of Patients With In-hospital Pulmonary Morbidity  
[units: Percent of participants]
  7.3     10.5  


Statistical Analysis 1 for Percentage of Patients With In-hospital Pulmonary Morbidity
Groups [1] All groups
Method [2] Chi-squared
P Value [3] < 0.0001
Mean Difference (Net) [4] -3.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



6.  Primary:   Percentage of Patients With In-hospital Infection Morbidity   [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type Primary
Measure Title Percentage of Patients With In-hospital Infection Morbidity
Measure Description 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  3525     3525  
Percentage of Patients With In-hospital Infection Morbidity  
[units: Percent of participants]
  9.2     11.5  


Statistical Analysis 1 for Percentage of Patients With In-hospital Infection Morbidity
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.0012
Mean Difference (Net) [4] -2.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



7.  Primary:   Percentage of Patients With In-hospital Thromboembolic Morbidity   [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type Primary
Measure Title Percentage of Patients With In-hospital Thromboembolic Morbidity
Measure Description Thromboembolic morbidity was identified using ICD-9-CM diagnosis and procedure codes for pulmonary embolishm 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  3525     3525  
Percentage of Patients With In-hospital Thromboembolic Morbidity  
[units: Percent of participants]
  1.2     2.1  


Statistical Analysis 1 for Percentage of Patients With In-hospital Thromboembolic Morbidity
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.0030
Mean Difference (Net) [4] -0.9
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



8.  Primary:   Percentage of Patients With In-hospital Other Morbidity   [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type Primary
Measure Title Percentage of Patients With In-hospital Other Morbidity
Measure Description Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complicaitons not elsewhere classified.
Time Frame Participants were followed up until their hospital discharge after bowel resection  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  3525     3525  
Percentage of Patients With In-hospital Other Morbidity  
[units: Percent of participants]
  0.6     0.7  


Statistical Analysis 1 for Percentage of Patients With In-hospital Other Morbidity
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.7637
Mean Difference (Net) [4] -0.1
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



9.  Primary:   Percentage of Patients Who Were Readmitted Within 15 Days of Discharge   [ Time Frame: Within 15 days of discharge from hospitalization for bowel resection ]

Measure Type Primary
Measure Title Percentage of Patients Who Were Readmitted Within 15 Days of Discharge
Measure Description No text entered.
Time Frame Within 15 days of discharge from hospitalization for bowel resection  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  3525     3525  
Percentage of Patients Who Were Readmitted Within 15 Days of Discharge  
[units: Percent of partcipants]
  7.4     8.7  


Statistical Analysis 1 for Percentage of Patients Who Were Readmitted Within 15 Days of Discharge
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.0402
Mean Difference (Net) [4] -1.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



10.  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 ]

Measure Type Primary
Measure Title Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge
Measure Description No text entered.
Time Frame Between 16-30 days after hospital discharge after bowel resection  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  3525     3525  
Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge  
[units: Percent of participants]
  1.9     2.5  


Statistical Analysis 1 for Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.0755
Mean Difference (Net) [4] -0.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



11.  Primary:   Percentage of Patients Who Were Readmitted Within 30 Days of Discharge   [ Time Frame: Between 0-30 days after hospital discharge after bowel resection ]

Measure Type Primary
Measure Title Percentage of Patients Who Were Readmitted Within 30 Days of Discharge
Measure Description No text entered.
Time Frame Between 0-30 days after hospital discharge after bowel resection  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  3525     3525  
Percentage of Patients Who Were Readmitted Within 30 Days of Discharge  
[units: Percent of participants]
  9.3     11.2  


Statistical Analysis 1 for Percentage of Patients Who Were Readmitted Within 30 Days of Discharge
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.0532
Mean Difference (Net) [4] -1.9
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



12.  Primary:   Percentage of Patients Discharged to Various Locations   [ Time Frame: Hospital discharge after bowel resection ]

Measure Type Primary
Measure Title Percentage of Patients Discharged to Various Locations
Measure Description Location of discharge for patients who were admitted to the hospital for their bowel resection from home
Time Frame Hospital discharge after bowel resection  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  3525     3525  
Percentage of Patients Discharged to Various Locations  
[units: Percent of participants]
   
Health care facility     7.9     13.8  
Home     87.5     80.7  


Statistical Analysis 1 for Percentage of Patients Discharged to Various Locations
Groups [1] All groups
Method [2] Chi-squared
P Value [3] < 0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



13.  Primary:   Intensive Care Unit Length of Stay   [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type Primary
Measure Title Intensive Care Unit Length of Stay
Measure Description No text entered.
Time Frame Participants were followed up until their hospital discharge after bowel resection  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  3525     3525  
Intensive Care Unit Length of Stay  
[units: Days]
Mean ± Standard Deviation
  0.3  ± 1.4     0.6  ± 2.4  


Statistical Analysis 1 for Intensive Care Unit Length of Stay
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] < 0.0001
Mean Difference (Net) [4] -0.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
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14.  Secondary:   Postoperative Length of Hospital Stay   [ Time Frame: Measured from the day after bowel resection to the day of hospital discharge ]

Measure Type Secondary
Measure Title Postoperative Length of Hospital Stay
Measure Description 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups
  Description
Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values
    Alvimopan Users     Matched Controls  
Number of Participants Analyzed  
[units: participants]
  2323     2323  
Postoperative Length of Hospital Stay  
[units: Days]
Mean ± Standard Deviation
  5.3  ± 3.1     6.4  ± 4.8  


Statistical Analysis 1 for Postoperative Length of Hospital Stay
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] < 0.0001
Mean Difference (Net) [4] -1.1
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant method information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
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  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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