Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT04299204
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2020-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Success of Pediatric Percutaneous Nephrolithotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D052878', 'term': 'Urolithiasis'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'the data into two groups. In group-1, PCNL was performed in the first 10 years period (1997-2007); in group-2, PCNL was performed in the second ten years period from 2008 to the present.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 553}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2020-03-02', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Efficacy of clinical experience of Percutaneous nephrolitotomy', 'timeFrame': 'over 20 years', 'description': 'The duration of clinical experience affects complication rates, success rates. Intraoperative and postoperative data was contained, preoperative and postoperative GFR (calculated with Cockcroft Gault equations), changing hemoglobin levels, transfusion rate, complications according to the Clavien classification.'}], 'secondaryOutcomes': [{'measure': 'Changing of complications managements', 'timeFrame': 'Over 20 years', 'description': 'Rate of and changing of Management of complications in pediatric patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urolithiasis', 'Pediatrics', 'Percutaneous'], 'conditions': ['Nephrolithiasis']}, 'referencesModule': {'references': [{'pmid': '26682755', 'type': 'RESULT', 'citation': 'Citamak B, Altan M, Bozaci AC, Koni A, Dogan HS, Bilen CY, Sahin A, Tekgul S. Percutaneous Nephrolithotomy in Children: 17 Years of Experience. J Urol. 2016 Apr;195(4 Pt 1):1082-7. doi: 10.1016/j.juro.2015.11.070. Epub 2015 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'Between June 1997-June 2018, 573 pediatric patients underwent PCNL for renal stone disease by senior surgeons. Data was disunited into 2 groups.\n\nThe study showed that PCNL is an operator-dependent procedure, with the improvement of outcomes over time, presumably due to increased operator experience and the involvement of a team member with substantial prior experience During 20 years, by gaining experience and with the development of new tools and optics, fluoroscopy time, operation time, blood loss and complication rates decreased and stone-free rates increased.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients with kidney stone\n\nExclusion Criteria:\n\n* Patients with a solitary kidney'}, 'identificationModule': {'nctId': 'NCT04299204', 'briefTitle': 'The Success of Pediatric Percutaneous Nephrolithotomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Osmaniye Government Hospital'}, 'officialTitle': 'Which Factor Affect the Success of Pediatric PCNL?: Single Center Experiences, Over 20 Years: Cohort Study', 'orgStudyIdInfo': {'id': 'OsmaniyeGH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Years 1997-2007', 'description': 'Group-1, PCNL was performed in the first 10 years period (Years 1997-2007);', 'interventionNames': ['Procedure: Percutaneous nephrolitotomy']}, {'type': 'EXPERIMENTAL', 'label': '2008- to the present', 'description': 'The PCNL was performed in the second ten years period from 2008 to the present.', 'interventionNames': ['Procedure: Percutaneous nephrolitotomy']}], 'interventions': [{'name': 'Percutaneous nephrolitotomy', 'type': 'PROCEDURE', 'description': 'Pediatric PCNL', 'armGroupLabels': ['2008- to the present', 'Years 1997-2007']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The data belonged to Cukurova University, Department of Urology'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osmaniye Government Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}