Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 7:12 AM
Study NCT ID:
NCT03712657
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2018-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ERAS for Pediatric Acute Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 893}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2018-10-07', 'studyFirstSubmitQcDate': '2018-10-18', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of stay', 'timeFrame': 'through study completion, an average of 7 days', 'description': 'less hospital length of stay'}], 'secondaryOutcomes': [{'measure': 'first time for postoperative feeding', 'timeFrame': 'up to 72 hours', 'description': 'earlier postoperative feeding'}, {'measure': 'first time for postoperative exercising', 'timeFrame': '1-2 days', 'description': 'earlier postoperative exercising'}, {'measure': 'rate of postoperative complication', 'timeFrame': '1 months', 'description': 'less postoperative complication'}, {'measure': 'rate of re-operation', 'timeFrame': '1 months', 'description': 'less rate of re-operation'}, {'measure': 'rate of re-admission', 'timeFrame': '1 months', 'description': 'less rate of re-admission'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERAS', 'Pediatric surgery', 'Emergency', 'Both of systolic and diastolic will be measured'], 'conditions': ['Pediatric Disorder', 'Complicated Appendicitis']}, 'descriptionModule': {'briefSummary': 'This multicenter, prospective randomized controlled study is designed to applicate perioperative Enhanced recovery after surgery (ERAS) management for children with acute complicated appendicitis, the aim is to promote postoperative recovery, shorten the hospital length of stay, and reduce the incidence of postoperative complications.', 'detailedDescription': 'The purpose of this study is through multi-center prospective RCT research, to discuss the application of ERAS in children with acute complicated appendicitis, including its preoperative rehydration, postoperative analgesia, preoperative and postoperative antibiotics application, as well as the discharge standards and so on. The major outcome is whether it can reduce the length of stay in hospital (LOS), secondary outcomes are included the incidence of postoperative complications and postoperative readmission rate, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages\\<14; no gender limitation;\n* Alvarado scores ≥7;\n* preoperative radiography examination indicated complicated appendicitis;\n* Patients or their legal representatives have signed "informed consent"\n\nExclusion Criteria:\n\n* complicated life-threatening disease;\n* perioperative exploration not appendicitis;\n* Recently participated in other clinical trials within 3 months;\n* Researchers found not fit to participate in this trial for any condition'}, 'identificationModule': {'nctId': 'NCT03712657', 'acronym': 'EPAA', 'briefTitle': 'ERAS for Pediatric Acute Appendicitis', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Multi-center Research Manual for the Perioperative Application of Enhanced Recovery After Surgery in Pediatric Acute Appendicitis', 'orgStudyIdInfo': {'id': 'TJH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERAS group', 'description': 'interventions: 1.preoperative pain control; 2.avoiding application of ureter; 3.avoiding application of gastric tube; 4.avoiding application of irrigation; 5.avoiding application of drainage; 6.early exercising postoperatively; 7.early oral feeding postoperatively; 8.early discharging.', 'interventionNames': ['Combination Product: ERAS']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'normal treatment'}], 'interventions': [{'name': 'ERAS', 'type': 'COMBINATION_PRODUCT', 'description': '1. preoperative pain control;\n2. avoiding application of ureter;\n3. avoiding application of gastric tube;\n4. avoiding application of irrigation;\n5. avoiding application of drainage;\n6. early exercising postoperatively;\n7. early oral feeding postoperatively;\n8. early discharging.', 'armGroupLabels': ['ERAS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Jiexiong Feng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital, HUST, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified individual participant data for all primary and secondary outcome measures will be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Feng Jiexiong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Feng Jiexiong', 'investigatorAffiliation': 'Tongji Hospital'}}}}