Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-01 @ 10:23 PM
Study NCT ID:
NCT06734403
Status:
COMPLETED
Last Update Posted:
2024-12-16
First Post:
2024-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urinary Calculi After Bladder Augmentation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}, {'id': 'D016135', 'term': 'Spinal Dysraphism'}], 'ancestors': [{'id': 'D052878', 'term': 'Urolithiasis'}, {'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': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D012816', 'term': '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': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-12-11', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of participants with urinary calculi', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Rate of participants with urinary calculi After bladder augmentation'}, {'measure': 'Location of urinary calculi in the participants', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'After bladder augmentation, urinary calculi can be seen on postoperative imaging such as abdominal ultrasound, CT scan, and MRI. The different locations of these calculi can be the kidneys, the ureters, the bladder, or the urethra. Each patient who has had urinary calculi will be reported, and the location of the calculi will be specified depending on the imaging results.'}], 'secondaryOutcomes': [{'measure': 'Time frame between surgery and occurence of urinary calculi in the participants After bladder augmentation', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Time frame between surgery and occurence of urinary calculi in the participants After bladder augmentation'}, {'measure': 'Management of urinary calculi after bladder augmentation in the participants', 'timeFrame': 'Through study completion, an average of 2 years', 'description': '3 main procedures help getting rid off urinary calculi: extracorporeal lithotripsy, endoscopic surgery or laparotomy. The patients were divided depending on the procedure that was used to remove the urinary calculi.'}, {'measure': 'Risk factors of urinary calculi after bladder augmentation in the participants', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Age, sex, type of bladder augmentation...'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary Calculus', 'Bladder Augmentation', 'Child', 'Retrospective Study'], 'conditions': ['Calculi, Urinary', 'Neurogenic Bladder Disorder', 'Spina Bifida', 'Child, Only']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to analyse the occurence of urinary calculi after bladder augmentation in children:\n\n* location of the calculi (kidney or bladder)\n* type of bladder augmentation with higher rate of urinary calculi and why\n* Find risk factors of urinary calculi in bladder augmentation (age, sex, other bladder procedures..)', 'detailedDescription': 'Study the data of patients younger than 18 years old, who underwent a bladder augmentation, complicated by urinary calculi.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients younger than 18 years old, with urinary calculi, after bladder augmentation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients younger than 18 years old, with urinary calculi, after bladder augmentation\n\nExclusion Criteria:\n\n* Patients older than 18 years old, with urinary calculi, after bladder augmentation'}, 'identificationModule': {'nctId': 'NCT06734403', 'acronym': 'LITAPED', 'briefTitle': 'Urinary Calculi After Bladder Augmentation in Children', 'nctIdAliases': ['NCT05861024'], 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Management of Patients Who Had Urolithiasis After Bladder Augmentation in Childhood', 'orgStudyIdInfo': {'id': 'M24DC1104'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ileocystoplasty', 'description': 'Urinary Calculi After Ileocystoplasty in Children', 'interventionNames': ['Other: Bladder Augmentation']}, {'label': 'Sigmoidocystoplasty', 'description': 'Urinary Calculi After Sigmoidocystoplasty in Children', 'interventionNames': ['Other: Bladder Augmentation']}], 'interventions': [{'name': 'Bladder Augmentation', 'type': 'OTHER', 'description': 'Bladder Augmentation using bowel loop (ileal or sigmoid loop)', 'armGroupLabels': ['Ileocystoplasty', 'Sigmoidocystoplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'state': 'Auvergne', 'country': 'France', 'facility': 'University Hospital, Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "In the name of anonymization the investigators won't share individual participant data"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Destinval Christelle', 'investigatorAffiliation': 'University Hospital, Clermont-Ferrand'}}}}