Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-01 @ 3:26 AM
Study NCT ID:
NCT04572204
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2020-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Grades 3-5 Renal Trauma in Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-04', 'studyFirstSubmitDate': '2020-09-27', 'studyFirstSubmitQcDate': '2020-09-27', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stabilization of haemodynamic status of the patient in the first 24-72 hours', 'timeFrame': '24 to 72 hours'}], 'secondaryOutcomes': [{'measure': 'Resolution of perinephric collection during follow up Triphasic MSCT abdomen and pelvis', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Trauma']}, 'descriptionModule': {'briefSummary': 'comparing conservative management versus interventional management in hemodynamically stable paediatric patient with blunt renal trauma, evidence suggests that there is a reduced rate of renal loss and blood transfusion in patients managed conservatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 children (age group 0-18 years) will be added to my study divided into two groups regardless of sex', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children ( age group 0-18) who are diagnosed to have renal tissue injury grade 3-5 by contrast CT\n\nExclusion Criteria:\n\n* Age group more than 18 years\n* Low grade renal trauma 1-2\n* Patients who get explored due to extra urologic indication without proper urologic assessment'}, 'identificationModule': {'nctId': 'NCT04572204', 'briefTitle': 'Management of Grades 3-5 Renal Trauma in Pediatrics', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Management of Grades 3-5 Renal Trauma in Pediatrics: A Prospective Case Series', 'orgStudyIdInfo': {'id': 'Renal trauma management'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conservative group'}, {'label': 'interventional group', 'interventionNames': ['Other: Surgical']}], 'interventions': [{'name': 'Surgical', 'type': 'OTHER', 'description': 'Minimal: Such as PCN insertion Endosopic: Such as DJ insertion Surgical: Repair, Partial or total nephrectomy Angioembolization', 'armGroupLabels': ['interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71717', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Ahmed Hamdan Gameel', 'investigatorAffiliation': 'Assiut University'}}}}