Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-23 @ 7:34 AM
Study NCT ID:
NCT05045560
Status:
COMPLETED
Last Update Posted:
2021-09-21
First Post:
2021-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Antenatal and Postnatal Data of Anorectal Malformations Diagnosed at Montpellier University Hospital Over a 10-year Period (2010-2020)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071056', 'term': 'Anorectal Malformations'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'NC'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-18', 'studyFirstSubmitDate': '2021-09-06', 'studyFirstSubmitQcDate': '2021-09-06', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of ante or post-natal diagnosispremolars', 'timeFrame': '1 day', 'description': 'Number of ante or post-natal diagnosis'}], 'secondaryOutcomes': [{'measure': 'Number of with or without associated antenatal anomalies', 'timeFrame': '1 day', 'description': 'Number of with or without associated antenatal anomalies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anorectal Malformations']}, 'descriptionModule': {'briefSummary': 'Objective :\n\nAnorectal malformations (ARMs) are part of a spectrum of malformations due to an abnormal separation between the urogenital and digestive tracts during embryonic life. The prevalence of ARM is 1/2000 - 1/5000 live births, making it a relatively common malformation.\n\nThe impact of an ARM depends mainly on the type of malformation, which can be difficult to evaluate in the antenatal period, and whether it is isolated or associated (50-80%) with other malformations or genetic syndromes. Only 1 to 16% of ARMs are diagnosed in the antenatal period.\n\nThe objective of this study is to compare cases of prenatal diagnosis of ARM, cases of postnatal diagnosis of ARM with other antenatal ultrasound abnormalities, and those with normal antenatal ultrasound, in terms of management and functional prognosis, to identify ways to improve prenatal counseling.\n\nMaterials and methods :\n\nIn this retrospective monocentric study, the investigators have included all fetuses and newborns born between January 2010 and September 2020 with anorectal malformations, diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier. The Krickenbeck classification was used to classify the ARMs and to assess the functional prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all fetuses and newborns born between January 2010 and September 2020 with anorectal malformations, diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* fetuses and newborns born between January 2010 and September 2020 with anorectal malformations\n* diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier.\n\nExclusion criteria:\n\n* foreign-born patient\n* anorectal malformation associated with an abdominal wall defect'}, 'identificationModule': {'nctId': 'NCT05045560', 'briefTitle': 'Study of Antenatal and Postnatal Data of Anorectal Malformations Diagnosed at Montpellier University Hospital Over a 10-year Period (2010-2020)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Study of Antenatal and Postnatal Data of Anorectal Malformations Diagnosed at Montpellier University Hospital Over a 10-year Period (2010-2020) : Why and How to Improve Antenatal Counseling ?', 'orgStudyIdInfo': {'id': 'RECHMPL20_0616'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'antenatal diagnosis of anorectal malformation', 'description': 'Groupe 1 : antenatal diagnosis of anorectal malformation'}, {'label': 'postnatal diagnosis of anorectal malfiormation with associated anomalies on antenatal ultrasound', 'description': 'Groupe 2 : postnatal diagnosis of anorectal malfiormation with associated anomalies on antenatal ultrasound'}, {'label': 'postnatal diagnosis of anorectal malformation with anormal antenatal ultrasound', 'description': 'Groupe 3 : postnatal diagnosis of anorectal malformation with anormal antenatal ultrasound'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Florent Fuchs, MD; PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}