Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-27 @ 5:51 AM
Study NCT ID:
NCT01143259
Status:
COMPLETED
Last Update Posted:
2014-09-04
First Post:
2010-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use
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'}, {'id': 'D020959', 'term': 'Polyethylene'}], 'ancestors': [{'id': 'D011095', 'term': 'Polyethylenes'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'matthew.peters@imail.org', 'phone': '801-442-3703', 'title': 'Matthew Peters RN MS', 'organization': 'Intermountain Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 Days after hospital discharge', 'eventGroups': [{'id': 'EG000', 'title': '300 mg Polyethylene', 'description': 'Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.', 'otherNumAtRisk': 136, 'otherNumAffected': 13, 'seriousNumAtRisk': 136, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Alvimopan', 'description': 'Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.', 'otherNumAtRisk': 138, 'otherNumAffected': 3, 'seriousNumAtRisk': 138, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Post Operative Ileus', 'notes': 'National Surgical Quality Improvement Project definition-presence of nasogastric tube or order for nothing by mouth \\> postoperative day 4)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measure of Improvement Over the Standard', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg Polyethylene', 'description': 'Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.'}, {'id': 'OG001', 'title': 'Alvimopan', 'description': 'Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.97', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '30.2'}, {'value': '3.98', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '28.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day]', 'description': 'Determine if alvimopan addition to the multidisciplinary care process will result in decreased length of stay compared with the multidisciplinary care process plus placebo. Length of stay is determined by how many days a patient stays in the hospital. This is calculated by subtracting the discharge date from the admit date.', 'unitOfMeasure': 'Days in the hospital', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.'}, {'type': 'SECONDARY', 'title': 'Hospital Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg Polyethylene', 'description': 'Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.'}, {'id': 'OG001', 'title': 'Alvimopan', 'description': 'Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '14,520', 'groupId': 'OG000', 'lowerLimit': '6170', 'upperLimit': '78,521'}, {'value': '12,834', 'groupId': 'OG001', 'lowerLimit': '5,788', 'upperLimit': '78,708'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Upon discharge', 'description': 'Total Cost of hospital stay inflation adjusted to 2010 dollars.', 'unitOfMeasure': 'Dollars', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '300 mg Polyethylene', 'description': 'Control Group : The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.'}, {'id': 'FG001', 'title': 'Alvimopan', 'description': 'Treatment Group : The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Date of first enrollment5-24-2010 Date of last enrollment 6-13-2012 Patients were identified in surgeons office and then screen by study coordinators for eligibility.', 'preAssignmentDetails': 'Most common exclusion were patients with history of opioid us \\> 3 doses in 7 days prior to surgery.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '300 mg Polyethylene', 'description': 'Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.'}, {'id': 'BG001', 'title': 'Alvimopan', 'description': 'Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '89'}, {'value': '61', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '87'}, {'value': '61', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '89'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Mean BMI', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '60'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '51'}, {'value': '28', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Kg/M^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Total Cases Using An Open Approach', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'This only includes those surgical cases that were used in the analysis of the study which had surgery with an open approach versus laparoscopic.', 'unitOfMeasure': 'Cases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-25', 'studyFirstSubmitDate': '2010-05-24', 'resultsFirstSubmitDate': '2014-01-07', 'studyFirstSubmitQcDate': '2010-06-11', 'lastUpdatePostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-15', 'studyFirstPostDateStruct': {'date': '2010-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of Improvement Over the Standard', 'timeFrame': 'Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day]', 'description': 'Determine if alvimopan addition to the multidisciplinary care process will result in decreased length of stay compared with the multidisciplinary care process plus placebo. Length of stay is determined by how many days a patient stays in the hospital. This is calculated by subtracting the discharge date from the admit date.'}], 'secondaryOutcomes': [{'measure': 'Hospital Cost', 'timeFrame': 'Upon discharge', 'description': 'Total Cost of hospital stay inflation adjusted to 2010 dollars.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ileus', 'Post operative ileus'], 'conditions': ['Ileus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the addition of alvimopan to our care process model for colon resection patients will decrease length of stay. The care process model is a combination of optimal IV fluid management, early feeding, early ambulation, patient education, and pain management.', 'detailedDescription': 'Narcotic pain medicines bind mu-opioid receptors in the bowel and delay the return of normal function. Alvimopan is a peripherally acting mu-opioid receptor antagonist that blocks mu-opioid receptors in the gastrointestinal tract but does not compromise central nervous system-mediated opioid-based analgesia. Length of stay is an important surrogate measure of quality after colon surgery and the most common reason for prolonged Length of Stay after abdominal surgery is delayed gastrointestinal recovery (postoperative ileus).\n\nThe Food and Drug Administration has approved alvimopan (dosed preoperatively and twice daily postoperatively for up to 15 in-hospital doses) for the acceleration of upper and lower gastrointestinal recovery after partial bowel resection with primary anastomosis. In the 5 phase III alvimopan efficacy trials, a simple standardized accelerated postoperative care pathway was used rather than a comprehensive, multidisciplinary colon surgery care process model that is used by Intermountain Healthcare. In the most recently completed alvimopan phase III trial, the mean postoperative length of stay was 5.2 days whereas the mean length of stay at Intermountain Healthcare is 4.4 days without the addition of alvimopan to the multidisciplinary colon care process model.\n\nThis trial will investigate if the addition of alvimopan to the Intermountain Healthcare multidisciplinary care process can decrease length of stay compared with the multidisciplinary care process plus placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18\n2. Patient scheduled to receive opioid-based postoperative pain management ≥ 48 hrs\n3. Elective colon/rectal resection with anastomosis as primary procedure\n4. Patient enrolled in multidisciplinary colon care process\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Chronic opioid use or \\> 3 doses in 7 days prior to surgery\n3. History of multiple previous abdominal operations, gastrectomy, bariatric surgery, short bowel syndrome\n4. Complete bowel obstruction\n5. Patients with end-stage renal disease as defined by the need for dialysis and the commonly accepted threshold for dialysis is a Glomerular Filtration Rate of \\< 15.\n6. Patients with severe hepatic impairment (Childs-Pugh class C)\n7. ASA 4 or 5 (ASA 4 s incapacitating systemic disease that is a constant threat to life)\n8. Non-English speaking patients'}, 'identificationModule': {'nctId': 'NCT01143259', 'briefTitle': "Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use", 'organization': {'class': 'OTHER', 'fullName': 'Intermountain Health Care, Inc.'}, 'officialTitle': "A Randomized, Double Blind, Placebo Controlled Study to Study Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use", 'orgStudyIdInfo': {'id': 'Intermountain Alvimopan1017978'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '300 mg Polyethylene', 'interventionNames': ['Drug: 300 mg Polyethylene']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alvimopan', 'interventionNames': ['Drug: Alvimopam']}], 'interventions': [{'name': 'Alvimopam', 'type': 'DRUG', 'otherNames': ['Entereg'], 'description': 'The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.', 'armGroupLabels': ['Alvimopan']}, {'name': '300 mg Polyethylene', 'type': 'DRUG', 'description': 'The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.', 'armGroupLabels': ['300 mg Polyethylene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84003', 'city': 'American Fork', 'state': 'Utah', 'country': 'United States', 'facility': 'American Fork Hospital', 'geoPoint': {'lat': 40.3769, 'lon': -111.79576}}, {'zip': '84721', 'city': 'Cedar City', 'state': 'Utah', 'country': 'United States', 'facility': 'Valley View Hospital', 'geoPoint': {'lat': 37.67748, 'lon': -113.06189}}, {'zip': '84341', 'city': 'Logan', 'state': 'Utah', 'country': 'United States', 'facility': 'Logan Regional Hospital', 'geoPoint': {'lat': 41.73549, 'lon': -111.83439}}, {'zip': '84157', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermoutain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84403', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'McKay-Dee Hospital', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '84604', 'city': 'Provo', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Valley', 'geoPoint': {'lat': 40.23384, 'lon': -111.65853}}, {'zip': '84103', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'LDS Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84094', 'city': 'Sandy City', 'state': 'Utah', 'country': 'United States', 'facility': 'Alta View Hospital', 'geoPoint': {'lat': 40.59161, 'lon': -111.8841}}, {'zip': '84790', 'city': 'St. George', 'state': 'Utah', 'country': 'United States', 'facility': 'Dixie Regional', 'geoPoint': {'lat': 37.10415, 'lon': -113.58412}}], 'overallOfficials': [{'name': 'Bob Moesinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Health Care, Inc.'}, {'name': 'Matthew Peters, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Intermountain Health Care, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intermountain Health Care, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}