Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-30 @ 9:04 AM
Study NCT ID:
NCT01150760
Status:
COMPLETED
Last Update Posted:
2015-08-07
First Post:
2010-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Patients Not Receiving Alvimopan in the Premier Perspective Database
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045823', 'term': 'Ileus'}], 'ancestors': [{'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C419502', 'term': 'alvimopan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Adverse events were not collected in this retrospective observational study.', 'eventGroups': [{'id': 'EG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'OG000'}, {'value': '3525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.6', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': 'All-cause', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \\[for the alvimopan cohort\\] during their hospitalization)'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'OG000'}, {'value': '3525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000'}, {'value': '35.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-5.9', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': '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.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \\[for the alvimopan cohort\\] during their hospitalization)'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With In-hospital Cardiovascular Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'OG000'}, {'value': '3525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-4.6', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': '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).', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \\[for the alvimopan cohort\\] during their hospitalization)'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With In-hospital Cerebrovascular Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'OG000'}, {'value': '3525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.3', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': '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.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \\[for the alvimopan cohort\\] during their hospitalization)'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With In-hospital Pulmonary Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'OG000'}, {'value': '3525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '10.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-3.2', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': '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.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \\[for the alvimopan cohort\\] during their hospitalization)'}, {'type': 'SECONDARY', 'title': 'Postoperative Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2323', 'groupId': 'OG000'}, {'value': '2323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-1.1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured from the day after bowel resection to the day of hospital discharge', 'description': 'Calendar day of discharge - calendar day of surgery = postoperative length of stay', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Modified intent-to-treat (included patients who met all base population, inclusion and exclusion criteria, received ≥ 3 and ≤ 15 doses of alvimopan \\[for alvimopan cohort\\] during the patient's hospitalization, and received parenteral opioid on ≥ 1 postoperative day)", 'anticipatedPostingDate': '2010-08'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With In-hospital Infection Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'OG000'}, {'value': '3525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-2.3', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': '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.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \\[for the alvimopan cohort\\] during their hospitalization)'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With In-hospital Thromboembolic Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'OG000'}, {'value': '3525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.9', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': '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.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \\[for the alvimopan cohort\\] during their hospitalization)'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With In-hospital Other Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'OG000'}, {'value': '3525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7637', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.1', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': 'Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complications not elsewhere classified.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \\[for the alvimopan cohort\\] during their hospitalization)'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Who Were Readmitted Within 15 Days of Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'OG000'}, {'value': '3525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '8.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0402', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-1.3', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 15 days of discharge from hospitalization for bowel resection', 'unitOfMeasure': 'Percent of partcipants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \\[for the alvimopan cohort\\] during the patient's hospitalization)", 'anticipatedPostingDate': '2010-08'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'OG000'}, {'value': '3525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0755', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.6', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Between 16-30 days after hospital discharge after bowel resection', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \\[for the alvimopan cohort\\] during the patient's hospitalization)", 'anticipatedPostingDate': '2010-08'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Who Were Readmitted Within 30 Days of Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'OG000'}, {'value': '3525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '11.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0532', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-1.9', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Between 0-30 days after hospital discharge after bowel resection', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \\[for the alvimopan cohort\\] during the patient's hospitalization)", 'anticipatedPostingDate': '2010-08'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Discharged to Various Locations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'OG000'}, {'value': '3525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'title': 'Health care facility', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '13.8', 'groupId': 'OG001'}]}]}, {'title': 'Home', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}, {'value': '80.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Hospital discharge after bowel resection', 'description': 'Location of discharge for patients who were admitted to the hospital for their bowel resection from home', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \\[for the alvimopan cohort\\] during the patient's hospitalization)", 'anticipatedPostingDate': '2010-08'}, {'type': 'PRIMARY', 'title': 'Intensive Care Unit Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'OG000'}, {'value': '3525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'OG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-0.3', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan \\[for the alvimopan cohort\\] during the patient's hospitalization)", 'anticipatedPostingDate': '2010-08'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'FG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3525'}, {'groupId': 'FG001', 'numSubjects': '3525'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3525'}, {'groupId': 'FG001', 'numSubjects': '3525'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3525', 'groupId': 'BG000'}, {'value': '3525', 'groupId': 'BG001'}, {'value': '7050', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alvimopan Users', 'description': 'Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)'}, {'id': 'BG001', 'title': 'Matched Controls', 'description': 'Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '14.7', 'groupId': 'BG001'}, {'value': '61.9', 'spread': '14.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1847', 'groupId': 'BG000'}, {'value': '1872', 'groupId': 'BG001'}, {'value': '3719', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1678', 'groupId': 'BG000'}, {'value': '1653', 'groupId': 'BG001'}, {'value': '3331', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '331', 'groupId': 'BG000'}, {'value': '368', 'groupId': 'BG001'}, {'value': '699', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '2675', 'groupId': 'BG000'}, {'value': '2543', 'groupId': 'BG001'}, {'value': '5218', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '519', 'groupId': 'BG000'}, {'value': '614', 'groupId': 'BG001'}, {'value': '1133', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Procedure type', 'classes': [{'title': 'Laparoscopic colon or rectal resection', 'categories': [{'measurements': [{'value': '1427', 'groupId': 'BG000'}, {'value': '1427', 'groupId': 'BG001'}, {'value': '2854', 'groupId': 'BG002'}]}]}, {'title': 'Open colon or rectal resection', 'categories': [{'measurements': [{'value': '1171', 'groupId': 'BG000'}, {'value': '1171', 'groupId': 'BG001'}, {'value': '2342', 'groupId': 'BG002'}]}]}, {'title': 'Laparoscopic or open colon or rectal resection', 'categories': [{'measurements': [{'value': '424', 'groupId': 'BG000'}, {'value': '424', 'groupId': 'BG001'}, {'value': '848', 'groupId': 'BG002'}]}]}, {'title': 'Laparoscopic or open small bowel resection', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}]}, {'title': 'Laparoscopic or open ostomy takedown, bypass,other', 'categories': [{'measurements': [{'value': '322', 'groupId': 'BG000'}, {'value': '322', 'groupId': 'BG001'}, {'value': '644', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Category of bowel resection that patients underwent during their hospitalization', 'unitOfMeasure': 'Participants'}, {'title': 'Surgeon type', 'classes': [{'title': 'General surgeon', 'categories': [{'measurements': [{'value': '1809', 'groupId': 'BG000'}, {'value': '1809', 'groupId': 'BG001'}, {'value': '3618', 'groupId': 'BG002'}]}]}, {'title': 'Colorectal surgeon', 'categories': [{'measurements': [{'value': '1357', 'groupId': 'BG000'}, {'value': '1357', 'groupId': 'BG001'}, {'value': '2714', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '359', 'groupId': 'BG000'}, {'value': '359', 'groupId': 'BG001'}, {'value': '718', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "The type of surgeon that performed the patient's bowel resection during their hospitalization", 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7050}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-16', 'studyFirstSubmitDate': '2010-06-23', 'resultsFirstSubmitDate': '2010-08-17', 'studyFirstSubmitQcDate': '2010-06-24', 'lastUpdatePostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-17', 'studyFirstPostDateStruct': {'date': '2010-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Who Died', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': 'All-cause'}, {'measure': 'Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': '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.'}, {'measure': 'Percentage of Patients With In-hospital Cardiovascular Morbidity', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': '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).'}, {'measure': 'Percentage of Patients With In-hospital Cerebrovascular Morbidity', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': '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.'}, {'measure': 'Percentage of Patients With In-hospital Pulmonary Morbidity', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': '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.'}, {'measure': 'Percentage of Patients With In-hospital Infection Morbidity', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': '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.'}, {'measure': 'Percentage of Patients With In-hospital Thromboembolic Morbidity', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': '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.'}, {'measure': 'Percentage of Patients With In-hospital Other Morbidity', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection', 'description': 'Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complications not elsewhere classified.'}, {'measure': 'Percentage of Patients Who Were Readmitted Within 15 Days of Discharge', 'timeFrame': 'Within 15 days of discharge from hospitalization for bowel resection'}, {'measure': 'Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge', 'timeFrame': 'Between 16-30 days after hospital discharge after bowel resection'}, {'measure': 'Percentage of Patients Who Were Readmitted Within 30 Days of Discharge', 'timeFrame': 'Between 0-30 days after hospital discharge after bowel resection'}, {'measure': 'Percentage of Patients Discharged to Various Locations', 'timeFrame': 'Hospital discharge after bowel resection', 'description': 'Location of discharge for patients who were admitted to the hospital for their bowel resection from home'}, {'measure': 'Intensive Care Unit Length of Stay', 'timeFrame': 'Participants were followed up until their hospital discharge after bowel resection'}], 'secondaryOutcomes': [{'measure': 'Postoperative Length of Hospital Stay', 'timeFrame': 'Measured from the day after bowel resection to the day of hospital discharge', 'description': 'Calendar day of discharge - calendar day of surgery = postoperative length of stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GI recovery after bowel resection', 'morbidity after bowel resection', 'mortality', 'readmission', 'length of stay'], 'conditions': ['Ileus']}, 'referencesModule': {'references': [{'pmid': '22388106', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective cohort study using the medical claims Premier/Care Science database. The study time frame was from January 1, 2009 through December 31, 2009.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years at discharge\n* 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\n* Discharged within the study dates\n* Surgery at a participating Premier/Care Sciences hospital\n\nExclusion Criteria:\n\n* Had a diverting ostomy without a primary anastomosis during the index hospitalization\n* Had a trauma diagnosis\n* 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)\n* 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'}, 'identificationModule': {'nctId': 'NCT01150760', 'briefTitle': 'Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Patients Not Receiving Alvimopan in the Premier Perspective Database', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}, 'officialTitle': 'Comparison of Clinical Outcomes in Bowel Resection Patients Receiving Alvimopan vs. Patients Not Receiving Alvimopan in the Premier Perspective/Care Science Database', 'orgStudyIdInfo': {'id': 'Premier clinical outcomes'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alvimopan Users', 'interventionNames': ['Drug: Alvimopan']}, {'label': 'Matched controls'}], 'interventions': [{'name': 'Alvimopan', 'type': 'DRUG', 'otherNames': ['Entereg'], 'description': 'At least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection', 'armGroupLabels': ['Alvimopan Users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28208', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Premier database', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Lee Techner, DPM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}