Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
Study NCT ID:
NCT03968666
Status:
UNKNOWN
Last Update Posted:
2022-02-15
First Post:
2019-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compliance With Enhanced Recovery After Surgery Protocol (ERAS) in Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-05-28', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': '2 weeks', 'description': 'Days from surgery to discharge from the hospital'}], 'secondaryOutcomes': [{'measure': 'Readmission', 'timeFrame': '2 weeks', 'description': 'Admission to hospital after discharge'}, {'measure': 'Mortality', 'timeFrame': '2 weeks', 'description': 'Number of fatalities after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'The concept of "enhanced recovery" was introduced by European anesthesiologists and surgeons who challenged traditional clinical practices involved in peri-operative care in 1990s. The goal of enhanced recovery programs (ERP) is to maintain normal physiology thereby decreasing complications. It focuses on peri-operative optimization of patient care. It was originally created for open colorectal surgeries but now has shown benefit in various surgical specialities including thoracic surgery, vascular surgery, hepatobiliary as well as gynecological surgery.\n\nThe successful implementation of structured ERAS program requires an ERAS protocol, audit system and a multidisciplinary team. The investigators will evaluate the effect of compliance with the protocol and outcomes such as length of stay, readmissions, morbidity and mortality.', 'detailedDescription': 'After approval by the Institutional Review Board, the investigators plan to retrospectively study gynecological patients who underwent ERAS protocol at Augusta University Medical Center between January 2017 and February 2019.\n\nThis is a retrospective observational study to evaluate the outcomes of patients who had ERAS protocol during their surgery.\n\nDemographic and outcome variables will be obtained from the institutional health documentation system. The investigators will collect demographic variables (age, ASA status), morphometric measurements (body mass index), time from enrollment to ERAS protocol, hospitalization length of stay, and readmission rate. The investigators will also record the documentation of the ERAS protocol interventions against the ERAS protocol approved by the institution. The investigators will assess the effect of the degree of compliance on outcome variables.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for benign gynecologic surgery who underwent ERAS protocol', 'genderDescription': 'Gynecological surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All elective benign gynecological surgical patients enrolled under ERAS protocol\n\nExclusion Criteria:\n\n* History of oncologic pathologies'}, 'identificationModule': {'nctId': 'NCT03968666', 'briefTitle': 'Compliance With Enhanced Recovery After Surgery Protocol (ERAS) in Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'Evaluation of Compliance With Enhanced Recovery After Surgery (ERAS) Protocol in Benign Gynecological Surgical Patients', 'orgStudyIdInfo': {'id': '1396793'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gynecological surgery with ERAS protocol', 'description': 'Patients scheduled for benign gynecological surgery under ERAS protocol'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steffen Meiler, MD', 'role': 'CONTACT', 'email': 'smeiler@augusta.edu', 'phone': '706-721-3671'}], 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'centralContacts': [{'name': 'Efrain Riveros Perez, MD', 'role': 'CONTACT', 'email': 'eriverosperez@augusta.edu', 'phone': '3304074681'}], 'overallOfficials': [{'name': 'Efrain Riveros Perez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augusta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Efrain Riveros Perez, MD', 'investigatorAffiliation': 'Augusta University'}}}}