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OpenTrials
Completed

NCT Number: NCT01150760

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

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Key information

Conditions

Ileus Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Premier database

Charlotte, North Carolina, 28208, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alvimopan

Drug

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

Other names: Entereg

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Comparison of Clinical Outcomes in Bowel Resection Patients Receiving Alvimopan vs. Patients Not Receiving Alvimopan in the Premier Perspective/Care Science Database

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 25, 2010
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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