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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 (Responsible Party):
Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT01150760
First received: June 23, 2010
Last updated: July 16, 2015
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.
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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 
Overall Participants Analyzed 
[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/Ethnicity, Customized 
[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 
[1] Category of bowel resection that patients underwent during their hospitalization
Surgeon type [1] 
[Units: Participants]
     
General surgeon   1809   1809   3618 
Colorectal surgeon   1357   1357   2714 
Other   359   359   718 
[1] 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 ]

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 ]

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

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

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

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  

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 alvimopan 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 
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
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Chi-squared
P Value [4] < 0.0001
Mean Difference (Net) [5] -3.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
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[3] Other relevant method information, such as adjustments or degrees of freedom:
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[4] 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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[5] Other relevant estimation information:
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6.  Primary:   Percentage of Patients With In-hospital Infection Morbidity   [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

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

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

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 ]

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 ]

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 ]

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

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

14.  Secondary:   Postoperative Length of Hospital Stay   [ Time Frame: Measured from the day after bowel resection to the day of hospital discharge ]


  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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