Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-04-17 @ 12:53 PM
Study NCT ID:
NCT03189550
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2017-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Recovery After Surgery in Colorectal Surgery: A Large-Scale Quality Improvement Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 664}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-19', 'studyFirstSubmitDate': '2017-03-25', 'studyFirstSubmitQcDate': '2017-06-13', 'lastUpdatePostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of surgical site infection', 'timeFrame': 'Up to 30 days postoperative'}], 'secondaryOutcomes': [{'measure': 'ICU length of stay', 'timeFrame': 'Up to 30 days postoperative'}, {'measure': 'Time on ventilator', 'timeFrame': 'Up to 30 days postoperative'}, {'measure': 'Post operative pain assessment using 11-point Numeric Pain Rating Scale (NRS)', 'timeFrame': 'Up to 30 days postoperative', 'description': 'Post operative pain assessed using NRS when 0 is no nausea and 10 is worst pain.'}, {'measure': 'Post operative anti emetic consumption', 'timeFrame': 'Up to 30 days postoperative'}, {'measure': 'Occurrence of postoperative complications', 'timeFrame': 'Up to 30 days postoperative'}, {'measure': 'Analgesia consumption', 'timeFrame': 'Up to 30 days postoperative', 'description': 'Total opioid and non-opioid medication use'}, {'measure': 'Cardiac Index', 'timeFrame': '1 day', 'description': 'Using time traces for cardiac index during the perioperative period, the time in range of pre-defined parameters will be measured.'}, {'measure': 'Stroke volume', 'timeFrame': '1 day', 'description': 'Using time traces for stroke volume during the perioperative period, the time in range of pre-defined parameters will be measured.'}, {'measure': 'Systemic vascular resistance', 'timeFrame': '1 day', 'description': 'Using time traces for systemic vascular resistance during the perioperative period, the time in range of pre-defined parameters will be measured.'}, {'measure': 'Heart rate', 'timeFrame': '1 day', 'description': 'Using time traces for heart rate during the perioperative period, the time in range of pre-defined parameters will be measured.'}, {'measure': 'Hospital Length of stay (days)', 'timeFrame': 'Up to 30 days post operative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Surgery', 'Quality Improvement', 'Perioperative Care', 'ERAS']}, 'referencesModule': {'references': [{'pmid': '33292514', 'type': 'DERIVED', 'citation': 'McEvoy MD, Wanderer JP, Shi Y, Ramanujan KS, Geiger TM, Shotwell MS, Shaw AD, Hawkins AT, Martin BJ, Mythen MG, Sandberg WS. The effect of adding goal-directed hemodynamic management for elective patients in an established enhanced recovery program for colorectal surgery: results of quasi-experimental pragmatic trial. Perioper Med (Lond). 2020 Nov 23;9(1):35. doi: 10.1186/s13741-020-00163-3.'}]}, 'descriptionModule': {'briefSummary': 'Multimodal perioperative care pathways have evolved into enhanced recovery after surgery (ERAS). ERAS pathways improve the quality of patient care, reduce morbidity, and shorten length of stay. This project will test the hypothesis that implementation of a multi-modal ERAS perioperative care protocol in colorectal surgical patients will result in significantly reduced perioperative morbidity and mortality.', 'detailedDescription': 'Multimodal perioperative care pathways have evolved into enhanced recovery after surgery (ERAS). ERAS pathways improve the quality of patient care, reduce morbidity, and shorten length of stay. This large quality improvement project will compare outcomes after standard perioperative practice with those after the implementation of a multi-modal evidence based care pathway, including standardized preoperative preparation, perioperative goal-directed fluid therapy (GFDT), multi-modal perioperative pain management, post operative nausea and vomiting prevention, surgical care and bowel isolation, and surgical site infection prevention. This project will test the hypothesis that implementation of a multi-modal ERAS perioperative care protocol in colorectal surgical patients will result in significantly reduced perioperative morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who underwent colorectal surgery at Vanderbilt University Medical Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who underwent colorectal surgery at Vanderbilt University Medical Center and whose data is stored in the perioperative data warehouse.\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Weight \\<40 kg'}, 'identificationModule': {'nctId': 'NCT03189550', 'acronym': 'ERAS', 'briefTitle': 'Enhanced Recovery After Surgery in Colorectal Surgery: A Large-Scale Quality Improvement Project', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Enhanced Recovery After Surgery in Colorectal Surgery: A Large-Scale Quality Improvement Project', 'orgStudyIdInfo': {'id': '140558'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Historical control', 'description': 'Patients who underwent colorectal surgery with standard perioperative care starting from June 2014 and progressing backward in time.', 'interventionNames': ['Procedure: Standard perioperative care']}, {'label': 'ERAS without SOC noninvasive hemodynamic monitoring', 'description': 'Patients who underwent colorectal surgery after implementation of standard of care (SOC) ERAS perioperative care from July 2014 to February 2015', 'interventionNames': ['Procedure: ERAS perioperative care', 'Procedure: Standard perioperative care']}, {'label': 'ERAS with SOC noninvasive hemodynamic monitoring', 'description': 'Patients who underwent colorectal surgery after implementation of standard of care ERAS perioperative care with standard of care noninvasive hemodynamic monitoring (with the ClearSight System, Edwards Lifesciences) after February 2015', 'interventionNames': ['Procedure: ERAS perioperative care', 'Procedure: Standard perioperative care', 'Procedure: Noninvasive hemodynamic monitoring']}], 'interventions': [{'name': 'ERAS perioperative care', 'type': 'PROCEDURE', 'description': 'Standard of care implementation of multi-modal evidence-based care pathway, including standardized preoperative preparation (medical and diet), perioperative goal-directed fluid therapy, multi-modal perioperative pain management, postoperative nausea and vomiting prevention, surgical care and bowel isolation, and surgical site infection prevention', 'armGroupLabels': ['ERAS with SOC noninvasive hemodynamic monitoring', 'ERAS without SOC noninvasive hemodynamic monitoring']}, {'name': 'Standard perioperative care', 'type': 'PROCEDURE', 'description': 'Standard perioperative care prior to implementation of ERAS care pathway', 'armGroupLabels': ['ERAS with SOC noninvasive hemodynamic monitoring', 'ERAS without SOC noninvasive hemodynamic monitoring', 'Historical control']}, {'name': 'Noninvasive hemodynamic monitoring', 'type': 'PROCEDURE', 'description': 'Standard of care perioperative noninvasive hemodynamic monitoring with the ClearSight System (Edwards LifeSciences)', 'armGroupLabels': ['ERAS with SOC noninvasive hemodynamic monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Matthew D McEvoy, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology', 'investigatorFullName': 'Matthew McEvoy', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}