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

NCT01150760 | Completed Results

• 1 other identifier: Premier clinical outcomes
• Study Type: observational
• Target: 7,050
• Locations: 1 country
• Sites: 1

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).

Conditions

Ileus

Keywords

GI recovery after bowel resection; morbidity after bowel resection; mortality; readmission; length of stay

Outcome Measures

Primary Outcomes (13)

• Percentage of Patients Who Died

  All-cause

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  Participants were followed up until their hospital discharge after bowel resection

• Percentage of Patients Who Were Readmitted Within 15 Days of Discharge

  Within 15 days of discharge from hospitalization for bowel resection

• Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge

  Between 16-30 days after hospital discharge after bowel resection

• Percentage of Patients Who Were Readmitted Within 30 Days of Discharge

  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

  Hospital discharge after bowel resection

• Intensive Care Unit Length of Stay

  Participants were followed up until their hospital discharge after bowel resection

Secondary Outcomes (1)

• Postoperative Length of Hospital Stay

  Measured from the day after bowel resection to the day of hospital discharge

Study Arms (2)

Alvimopan Users

Drug: Alvimopan

Matched controls

Interventions

Alvimopan DRUG

At least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection

Also known as: Entereg

Alvimopan Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Premier database

Charlotte, North Carolina, 28208, United States

Location

Related Publications (1)

• 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.

  PMID: 22388106 DERIVED

MeSH Terms

Conditions

Ileus

Interventions

alvimopan

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Lee Techner, DPM

  Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 25, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 7, 2015
• Results First Posted: September 8, 2010

Record last verified: 2010-09

Locations

US (1)