Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT06733194
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2024-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complications of Bladder Augmentation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}, {'id': 'D016135', 'term': 'Spinal Dysraphism'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009436', 'term': 'Neural Tube Defects'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2024-12-10', 'studyFirstSubmitQcDate': '2024-12-10', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical complications of bladder augmentation in children depending on the type of enterocystoplasty', 'timeFrame': '38 years', 'description': 'Observational study'}], 'secondaryOutcomes': [{'measure': "Impact of the participants' age on the occurrence of complications depending on the type of enterocystoplasty", 'timeFrame': '38 years', 'description': 'Observational study'}, {'measure': "Impact of the participants' sex on the occurrence of complications depending on the type of enterocystoplasty", 'timeFrame': '38 years', 'description': 'Observational study'}, {'measure': "Impact of the participants' type of neurogenic bladder on the occurrence of complications depending on the type of enterocystoplasty", 'timeFrame': '38 years', 'description': 'Observational study: the participants can have spina bifida, bladder exstrophy, anorectal malformation and if it has an impact on the occurrence of complications depending on the type of enterocystoplasty'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bladder Augmentation', 'Enterocystoplasty', 'Surgical Complications', 'Child', 'Retrospective Study'], 'conditions': ['Neurogenic Bladder Disorder', 'Spina Bifida', 'Complications of Surgical Procedures or Medical Care', 'Child, Only', 'Bladder Dysfunction']}, 'referencesModule': {'references': [{'pmid': '27142898', 'type': 'BACKGROUND', 'citation': 'Molina CA, Lima GJ, Cassini MF, Andrade MF, Facincani I, Tucci Junior S. Complications after bladder augmentation in children. Acta Cir Bras. 2016;31 Suppl 1:8-12. doi: 10.1590/S0102-86502016001300003.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to describe the complications in participants who underwent enterocystoplasty in childhood.\n\nThe main question\\[s\\] it aims to answer are:\n\n* what kind of complications are there\n* the kind of complications depending on the type of enterocystoplasty Participants data will be collected in the medical field. There is no comparison group.', 'detailedDescription': 'From 1982 to 2020, all patients who had an enterocystoplasty in childhood were collected.\n\nComplications were numbered depending on the type of enterocystoplasty and the investigators tried to find which risk factors exist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with dysfunctional bladder', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent a enterocystoplasty before 18 years old\n\nExclusion Criteria:\n\n* Patients who underwent a enterocystoplasty after 18 years old'}, 'identificationModule': {'nctId': 'NCT06733194', 'acronym': 'AVPED', 'briefTitle': 'Complications of Bladder Augmentation in Children', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Surgical Complications After Bladder Augmentation in Children: a Retrospective Study About 87 Patients', 'orgStudyIdInfo': {'id': 'M24DC1102'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'Patients who underwent an ileocystoplasty'}, {'label': 'Group S', 'description': 'Patients who underwent a sigmoidocystoplasty'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'state': 'Auvergne', 'country': 'France', 'facility': 'Clermont-Ferrand University Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Christelle Destinval', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "In the name of anonymization we won't share individual participant data"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Destinval Christelle', 'investigatorAffiliation': 'University Hospital, Clermont-Ferrand'}}}}