Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-04-18 @ 4:03 AM
Study NCT ID:
NCT02139059
Status:
UNKNOWN
Last Update Posted:
2015-02-03
First Post:
2014-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D001002', 'term': 'Anuria'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-02', 'studyFirstSubmitDate': '2014-05-13', 'studyFirstSubmitQcDate': '2014-05-14', 'lastUpdatePostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Return to normal creatinine', 'timeFrame': '1 week', 'description': 'period for return to normal creatinine in both groups'}, {'measure': 'stone free status', 'timeFrame': '1 week', 'description': 'success in removal of ureteric stones using ureteroscopy'}, {'measure': 'operative and early post operative complications', 'timeFrame': '1 week', 'description': 'Hematuria, Extravasation (perforation), mucosal complications, stone migration, failure of ureteric access, fever'}], 'secondaryOutcomes': [{'measure': 'ureteric stricture', 'timeFrame': '6 months', 'description': 'occurrence of ureteric stricture as a delayed complication'}, {'measure': 'period to reach stone free status bilaterally', 'timeFrame': '6 months', 'description': 'period to reach stone free status bilaterally after the treatment of the contralateral side'}, {'measure': 'number of times of exposure to general anesthesia', 'timeFrame': '6 months', 'description': 'number of times of exposure to general anesthesia during successive interventions to clear stones bilaterally'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anuria', 'children', 'ureteroscopy', 'initial urinary drainage', 'ureteric stones'], 'conditions': ['Acute Renal Failure', 'Anuria', 'Obstructive Uropathy', 'Ureteric Stones']}, 'descriptionModule': {'briefSummary': 'To compare staged ureteroscopy following initial urinary drainage versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure in children.', 'detailedDescription': 'To compare staged ureteroscopy following initial urinary drainage and stabilization of renal functions using percutaneous nephrostomy or double J stent versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure due to ureteric calculi in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children ≤12 years old presenting with Obstructive Anuria and Acute Renal Failure due to bilateral ureteric stones suitable for ureteroscopy.\n\nExclusion Criteria:\n\n* Fever, pyonephrosis or sepsis.\n* unstable patients are stabilized first by dialysis.'}, 'identificationModule': {'nctId': 'NCT02139059', 'briefTitle': 'Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Staged Ureteroscopy After Initial Urinary Drainage Versus Direct Ureteroscopy in the Treatment of Pediatric Obstructive Calcular Anuria', 'orgStudyIdInfo': {'id': '61179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'initial urinary drainage', 'description': 'initial urinary drainage to stabilize renal functions before ureteroscopy', 'interventionNames': ['Procedure: initial urinary drainage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'direct ureteroscopy', 'description': 'direct ureteroscopy without initial urinary drainage', 'interventionNames': ['Procedure: direct ureteroscopy']}], 'interventions': [{'name': 'initial urinary drainage', 'type': 'PROCEDURE', 'description': 'initial urinary drainage is done using nephrostomy or double J stent to stabilize renal functions. this is followed several days later by definitive ureteroscopy.', 'armGroupLabels': ['initial urinary drainage']}, {'name': 'direct ureteroscopy', 'type': 'PROCEDURE', 'description': 'direct ureteroscopy is done without initial urinary drainage and before return to normal chemistry. this is followed follow-up of renal functions for several days before treatment of the contralateral side.', 'armGroupLabels': ['direct ureteroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12222', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed S ElSheemy, A Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '12222', 'city': 'Cairo', 'status': 'NOT_YET_RECRUITING', 'country': 'Egypt', 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohammed S ElSheemy, A Professor', 'role': 'CONTACT', 'email': 'mohammedshemy@yahoo.com', 'phone': '01006117755'}], 'overallOfficials': [{'name': 'Mohammed S ElSheemy, A professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associte professor of urology', 'investigatorFullName': 'mohammed said elsheemy', 'investigatorAffiliation': 'Cairo University'}}}}