Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-13 @ 12:51 PM
Study NCT ID:
NCT03256669
Status:
COMPLETED
Last Update Posted:
2018-04-09
First Post:
2017-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Umblical Incision for Neonatal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-05', 'studyFirstSubmitDate': '2017-07-29', 'studyFirstSubmitQcDate': '2017-08-20', 'lastUpdatePostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'result', 'timeFrame': '1 week', 'description': 'surgical result successful or not'}], 'primaryOutcomes': [{'measure': 'operative time', 'timeFrame': '2 hours', 'description': 'how long the peration does take'}], 'secondaryOutcomes': [{'measure': 'cosmotic appearance', 'timeFrame': '2 weeks', 'description': 'shape of the wound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Surgery']}, 'descriptionModule': {'briefSummary': 'Abdominal exploration leave an ugly scar that live with the baby forever, laparoscopy can solve the problem to some extent by making a smaller scar but takes more time and need special surgical skills. Umbilical incision can combine the advantage of open and laparoscopy and avoid the drawbacks of both.', 'detailedDescription': 'six cases were subjected to the study 2 cases have duodenal atresia, one case has annular pancreas, one case has jujenal atresia chritmas tree, one case has jujenal web and a case of malrotation. all of them had made exploration by the umbilical incision, and no drains had been used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '20 Days', 'minimumAge': '20 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* neonate diagnosed radiologically\n\nExclusion Criteria:\n\n* unclear diagnosis'}, 'identificationModule': {'nctId': 'NCT03256669', 'briefTitle': 'Umblical Incision for Neonatal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Umblical Incision for Neonatal Surgey; is it Suitable', 'orgStudyIdInfo': {'id': '1a765'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'umbilical incision', 'description': 'neonates undergone surgery by umbilical incision', 'interventionNames': ['Procedure: umbilical incision']}], 'interventions': [{'name': 'umbilical incision', 'type': 'PROCEDURE', 'description': 'exploration through umbilical incision', 'armGroupLabels': ['umbilical incision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71526', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Ahmed Gamal Abdelmalek', 'investigatorAffiliation': 'Assiut University'}}}}