ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    22388106 [PUBMED-IDS]
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01150760
Recruitment Status : Completed
First Posted : June 25, 2010
Results First Posted : September 8, 2010
Last Update Posted : August 7, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

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).


Condition or disease Intervention/treatment
Ileus Drug: Alvimopan

Study Type : Observational
Actual Enrollment : 7050 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Comparison of Clinical Outcomes in Bowel Resection Patients Receiving Alvimopan vs. Patients Not Receiving Alvimopan in the Premier Perspective/Care Science Database
Study Start Date : April 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Alvimopan

Group/Cohort Intervention/treatment
Alvimopan Users Drug: Alvimopan
At least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection
Other Name: Entereg

Matched controls



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

  2. Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity [ Time Frame: 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.

  3. Percentage of Patients With In-hospital Cardiovascular Morbidity [ Time Frame: 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).

  4. Percentage of Patients With In-hospital Cerebrovascular Morbidity [ Time Frame: 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.

  5. Percentage of Patients With In-hospital Pulmonary Morbidity [ Time Frame: 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.

  6. Percentage of Patients With In-hospital Infection Morbidity [ Time Frame: 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.

  7. Percentage of Patients With In-hospital Thromboembolic Morbidity [ Time Frame: 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.

  8. Percentage of Patients With In-hospital Other Morbidity [ Time Frame: 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.

  9. Percentage of Patients Who Were Readmitted Within 15 Days of Discharge [ Time Frame: Within 15 days of discharge from hospitalization for bowel resection ]
  10. 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. Percentage of Patients Who Were Readmitted Within 30 Days of Discharge [ Time Frame: Between 0-30 days after hospital discharge after bowel resection ]
  12. Percentage of Patients Discharged to Various Locations [ Time Frame: Hospital discharge after bowel resection ]
    Location of discharge for patients who were admitted to the hospital for their bowel resection from home

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

Secondary Outcome Measures :
  1. Postoperative Length of Hospital Stay [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Retrospective cohort study using the medical claims Premier/Care Science database. The study time frame was from January 1, 2009 through December 31, 2009.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150760


Locations
United States, North Carolina
Premier database
Charlotte, North Carolina, United States, 28208
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
GlaxoSmithKline
Investigators
Study Director: Lee Techner, DPM Cubist Pharmaceuticals LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01150760     History of Changes
Other Study ID Numbers: Premier clinical outcomes
First Posted: June 25, 2010    Key Record Dates
Results First Posted: September 8, 2010
Last Update Posted: August 7, 2015
Last Verified: September 2010

Keywords provided by Cubist Pharmaceuticals LLC:
GI recovery after bowel resection
morbidity after bowel resection
mortality
readmission
length of stay

Additional relevant MeSH terms:
Alvimopan
Gastrointestinal Agents