IleusNCT01150760
Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Patients Not Receiving Alvimopan in the Premier Perspective Database
An observational study of Ileus, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileus
- What is being tested?
- Alvimopan
- How many people
- 7,050 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Aug 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Clinical Outcomes in Bowel Resection Patients Receiving Alvimopan vs. Patients Not Receiving Alvimopan in the Premier Perspective/Care Science Database
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).
- Conditions
- Ileus
- Being tested
- Alvimopan
- Keywords
- GI recovery after bowel resection, morbidity after bowel resection, mortality, readmission, length of stay
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlvimopanDrug
Also called Entereg
At least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection
| Study group | Role | What they receive |
|---|---|---|
| Alvimopan Users | Not described Receives: Drug: Alvimopan | |
| Matched controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Died
All-cause
Measured: Participants were followed up until their hospital discharge after bowel resection
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.
Measured: Participants were followed up until their hospital discharge after bowel resection
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).
Measured: Participants were followed up until their hospital discharge after bowel resection
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.
Measured: Participants were followed up until their hospital discharge after bowel resection
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.
Measured: Participants were followed up until their hospital discharge after bowel resection
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.
Measured: Participants were followed up until their hospital discharge after bowel resection
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.
Measured: Participants were followed up until their hospital discharge after bowel resection
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.
Measured: Participants were followed up until their hospital discharge after bowel resection
Percentage of Patients Who Were Readmitted Within 15 Days of Discharge
Measured: Within 15 days of discharge from hospitalization for bowel resection
Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge
Measured: Between 16-30 days after hospital discharge after bowel resection
Percentage of Patients Who Were Readmitted Within 30 Days of Discharge
Measured: Between 0-30 days after hospital discharge after bowel resection
Percentage of Patients Discharged to Various Locations
Location of discharge for patients who were admitted to the hospital for their bowel resection from home
Measured: Hospital discharge after bowel resection
Intensive Care Unit Length of Stay
Measured: Participants were followed up until their hospital discharge after bowel resection
Secondary outcomes (1)
Postoperative Length of Hospital Stay
Calendar day of discharge - calendar day of surgery = postoperative length of stay
Measured: Measured from the day after bowel resection to the day of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 7,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Lee Techner, DPM, Study director, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150760
- Sponsor's protocol ID
- Premier clinical outcomes
- Status last verified
- Sep 2010
- First submitted
- 23 Jun 2010
- Last updated
- 7 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Delaney CP, Craver C, Gibbons MM, Rachfal AW, VandePol CJ, Cook SF, Poston SA, Calloway M, Techner L. Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection. Ann Surg. 2012 Apr;255(4):731-8. doi: 10.1097/SLA.0b013e31824a36cc.
PubMed 22388106
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes in Bowel Resection Patients Receiving Alvimopan vs. Patients Not Receiving Alvimopan in the Premier Perspective/Care Science Database
- ClinicalTrials.gov ID
- NCT01150760
- Acronym / sponsor ID
- Premier clinical outcomes
- Conditions
- Ileus
- Keywords
- GI recovery after bowel resection, morbidity after bowel resection, mortality, readmission, length of stay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,050 participants (actual)
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Posted 8 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alvimopan Users | – | Drug: Alvimopan |
| Matched controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlvimopanAlso: EnteregAt least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection | Drug | Alvimopan Users |
Primary outcome
Percentage of Patients Who Died
Time frame: Participants were followed up until their hospital discharge after bowel resection
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
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
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
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
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
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
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
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.
Percentage of Patients Who Were Readmitted Within 15 Days of Discharge
Time frame: Within 15 days of discharge from hospitalization for bowel resection
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
Percentage of Patients Who Were Readmitted Within 30 Days of Discharge
Time frame: Between 0-30 days after hospital discharge after bowel resection
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
Intensive Care Unit Length of Stay
Time frame: Participants were followed up until their hospital discharge after bowel resection
1 secondary outcome
Postoperative Length of Hospital Stay
Time frame: Measured from the day after bowel resection to the day of hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22388106Delaney CP, Craver C, Gibbons MM, Rachfal AW, VandePol CJ, Cook SF, Poston SA, Calloway M, Techner L. Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection. Ann Surg. 2012 Apr;255(4):731-8. doi: 10.1097/SLA.0b013e31824a36cc.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Techner, DPM study director
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ileus, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Who Died (time frame: Participants were followed up until their hospital discharge after bowel resection). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01150760, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.