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:
Cubist Pharmaceuticals
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
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Purpose
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 | Intervention |
|---|---|
|
Ileus |
Drug: Alvimopan |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Cubist Pharmaceuticals:
Primary Outcome Measures:
- Percentage of Patients Who Died [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ] [ Designated as safety issue: No ]All-cause
- Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ] [ Designated as safety issue: No ]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 [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ] [ Designated as safety issue: No ]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 [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ] [ Designated as safety issue: No ]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 [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ] [ Designated as safety issue: No ]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 [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ] [ Designated as safety issue: No ]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 [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ] [ Designated as safety issue: No ]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.
- Percentage of Patients With In-hospital Other Morbidity [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ] [ Designated as safety issue: No ]Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complicaitons not elsewhere classified.
- Percentage of Patients Who Were Readmitted Within 15 Days of Discharge [ Time Frame: Within 15 days of discharge from hospitalization for bowel resection ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Percentage of Patients Who Were Readmitted Within 30 Days of Discharge [ Time Frame: Between 0-30 days after hospital discharge after bowel resection ] [ Designated as safety issue: No ]
- Percentage of Patients Discharged to Various Locations [ Time Frame: Hospital discharge after bowel resection ] [ Designated as safety issue: No ]Location of discharge for patients who were admitted to the hospital for their bowel resection from home
- Intensive Care Unit Length of Stay [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Postoperative Length of Hospital Stay [ Time Frame: Measured from the day after bowel resection to the day of hospital discharge ] [ Designated as safety issue: No ]Calendar day of discharge - calendar day of surgery = postoperative length of stay
| Enrollment: | 7050 |
| Study Start Date: | April 2010 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Alvimopan Users |
Drug: Alvimopan
At least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection
Other Name: Entereg
|
| Matched controls |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150760
Locations
| United States, North Carolina | |
| Premier database | |
| Charlotte, North Carolina, United States, 28208 | |
Sponsors and Collaborators
Cubist Pharmaceuticals
GlaxoSmithKline
Investigators
| Study Director: | Lee Techner, DPM | Cubist Pharmaceuticals |
More Information
No publications provided by Cubist Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Adolor |
| ClinicalTrials.gov Identifier: | NCT01150760 History of Changes |
| Other Study ID Numbers: | Premier clinical outcomes |
| Study First Received: | June 23, 2010 |
| Results First Received: | August 17, 2010 |
| Last Updated: | September 8, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cubist Pharmaceuticals:
|
GI recovery after bowel resection morbidity after bowel resection mortality readmission length of stay |
Additional relevant MeSH terms:
|
Ileus Intestinal Obstruction Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013