Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-26 @ 9:21 AM
Study NCT ID:
NCT04771832
Status:
COMPLETED
Last Update Posted:
2021-02-25
First Post:
2021-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ERAS in Gastrointerstinal Fistulas.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005402', 'term': 'Fistula'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2021-02-21', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'up to 24 weeks', 'description': 'Any surgical complications'}, {'measure': 'length of hospital stay', 'timeFrame': 'up to 24 weeks', 'description': 'duration of hospitalization'}, {'measure': 'postoperative nausea and vomiting', 'timeFrame': 'up to 24 weeks', 'description': 'prevalence of postoperative nausea and vomiting'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fistula', 'Surgery Site Fistula']}, 'referencesModule': {'references': [{'pmid': '34200140', 'type': 'DERIVED', 'citation': 'Klek S, Salowka J, Choruz R, Cegielny T, Welanyk J, Wilczek M, Szczepanek K, Pisarska-Adamczyk M, Pedziwiatr M. Enhanced Recovery after Surgery (ERAS) Protocol Is a Safe and Effective Approach in Patients with Gastrointestinal Fistulas Undergoing Reconstruction: Results from a Prospective Study. Nutrients. 2021 Jun 7;13(6):1953. doi: 10.3390/nu13061953.'}]}, 'descriptionModule': {'briefSummary': 'An enterocutaneous fistula (ECF) poses a major surgical problem. The definitive surgical repair of persistent fistulas remains a surgical challenge with a high rate of re-fistulation and mortality, and the reasons for that is not the surgical technique alone. Enhanced Recovery after Surgery (ERAS®) is an evidence-based multimodal perioperative protocol proven to reduce postoperative complications. The aim of the study was to assess the clinical value of ERAS protocol in surgical patients with ECF.', 'detailedDescription': "ERAS protocol was used in all patients scheduled for surgery for ECF at the Stanley Dudrick's Memorial Hospital in Skawina between 2011 and 2020. A multidisciplinary team (MDT) was in charge of the program and performed annual audits. A consecutive series of 100 ECF patients (44 F, 56 M, mean age 54.1) was evaluated. Postoperative complications rate, readmission rate, length of hospital stay, prevalence of postoperative nausea and vomiting were assessed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients scheduled for fistula surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgery for gastrointestinal fistula\n\nExclusion Criteria:\n\n* conservative treatment'}, 'identificationModule': {'nctId': 'NCT04771832', 'briefTitle': 'ERAS in Gastrointerstinal Fistulas.', 'organization': {'class': 'OTHER', 'fullName': "Stanley Dudrick's Memorial Hospital"}, 'officialTitle': 'Enhanced Recovery After Surgery (ERAS) Protocol is a Safe and Effective Approach in Patients With Gastrointestinal Fistulas Undergoing Reconstruction: Results From a Prospective Study.', 'orgStudyIdInfo': {'id': 'ERASGI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ERAS', 'description': 'Perioperative care with Enhanced Recovery After Surgery (ERAS) protocol', 'interventionNames': ['Procedure: ERAS']}], 'interventions': [{'name': 'ERAS', 'type': 'PROCEDURE', 'description': 'Enhanced Recovery After Surgery (ERAS) protocol is an evidence-based multimodal perioperative protocol focused on stress reduction and the promotion of a return to function', 'armGroupLabels': ['ERAS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32-050', 'city': 'Skawina', 'country': 'Poland', 'facility': "Stanley Dudrick's Memorial Hospital", 'geoPoint': {'lat': 49.97524, 'lon': 19.82869}}], 'overallOfficials': [{'name': 'Stanislaw Klek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Stanley Dudrick's Memorial Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Stanley Dudrick's Memorial Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Unit', 'investigatorFullName': 'Stanislaw Klek', 'investigatorAffiliation': "Stanley Dudrick's Memorial Hospital"}}}}