Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT05593861
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2022-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Enhanced Recovery After Surgery Implementation at Pediatric Surgery Practices in Mainland China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-22', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2022-10-22', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Barriers to implementation', 'timeFrame': 'immediately after all the questionnaires are collected', 'description': 'Barriers to implementation'}, {'measure': 'Outcomes of concern', 'timeFrame': 'immediately after all the questionnaires are collected', 'description': 'Outcomes of concern'}], 'primaryOutcomes': [{'measure': 'Element adherence', 'timeFrame': 'immediately after all the questionnaires are collected', 'description': 'Adherence to an element was determined if the frequency of practice reached specific thresholds as defined.'}], 'secondaryOutcomes': [{'measure': 'Factors associated with baseline ERAS utilization', 'timeFrame': 'immediately after all the questionnaires are collected', 'description': 'Factors associated with baseline ERAS utilization'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ERAS']}, 'referencesModule': {'references': [{'pmid': '32713714', 'type': 'BACKGROUND', 'citation': 'Vacek J, Davis T, Many BT, Close S, Blake S, Hu YY, Holl JL, Johnson J, Strople J, Raval MV. A baseline assessment of enhanced recovery protocol implementation at pediatric surgery practices performing inflammatory bowel disease operations. J Pediatr Surg. 2020 Oct;55(10):1996-2006. doi: 10.1016/j.jpedsurg.2020.06.021. Epub 2020 Jun 27.'}]}, 'descriptionModule': {'briefSummary': 'Enhanced recovery after surgery (ERAS) is a new mode to optimize perioperative management, the core of which is to reduce perioperative physiological and psychological trauma and stress damage, and accelerate postoperative rehabilitation. ERAS has been gradually introduced in pediatric surgery in recent years, however, there are limited reports on its overall implementation. We aimed to determine the popularity of ERAS among pediatric populations in mainland China.', 'detailedDescription': 'The application of ERAS in children with congenital biliary dilatation (CBD) was investigated. A total of 31 province-level administrative regions in mainland China were involved and each of them had at least one participating center. A questionnaire was designed to assess the baseline adherence of 17 recovery elements and chief pediatric surgeons at each center were invited to complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'chief pediatric surgeons at each center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chief pediatric surgeons at each center\n\nExclusion Criteria:\n\n* Incomplete questionnaire'}, 'identificationModule': {'nctId': 'NCT05593861', 'briefTitle': 'Assessment of Enhanced Recovery After Surgery Implementation at Pediatric Surgery Practices in Mainland China', 'organization': {'class': 'OTHER', 'fullName': "Nanjing Children's Hospital"}, 'officialTitle': 'Assessment of Enhanced Recovery After Surgery Implementation at Pediatric Surgery Practices in Mainland China: Based on a Survey of Performing Congenital Biliary Dilatation Operations', 'orgStudyIdInfo': {'id': 'NanjingCH13170'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'This investigation was conducted on chief surgeons at each center.', 'description': 'This investigation was conducted on chief surgeons at each center.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'NJMU', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Hua Xie, M.M.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing, China."}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weibing Tang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Weibing Tang', 'investigatorAffiliation': "Nanjing Children's Hospital"}}}}