Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT06199518
Status:
COMPLETED
Last Update Posted:
2024-01-10
First Post:
2023-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minimally Invasive Techniques for Treating Large Proximal Ureteral Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-28', 'studyFirstSubmitDate': '2023-12-28', 'studyFirstSubmitQcDate': '2023-12-28', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stone free rate (SFR)', 'timeFrame': 'immediate (initial SFR ) and 1 -month later (final SFR)', 'description': 'SFR is defined as no residual stones or fragments ≤ 4 mm.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endourology']}, 'descriptionModule': {'briefSummary': 'a prospective comparative study designed to compare the outcomes of transperitoneal Laparoscopic ureterolithotomy (T-LUL), mini-percutaneous antegrade ureteroscopy (A-URS) and retrograde ureteroscopy (R-URS) in treating patients with LPUS (15-20 mm). the following parameters were assessed and compared (demographic data and stones characteristics, Stone free rate and complications)', 'detailedDescription': 'we aimed in the current study to comprehensively evaluate and to compare the outcome of transperitoneal laparoscopic ureterolithtomy, retrograde ureteroscopy and mini-percutaneous antegrade ureteroscopy for management of large proximal ureteric stone (15 -20 mm) with regards to; operative time, stone free rate, success rate, hospital stay and complications.\n\nA total of 105 participants were enrolled in the trial between April 2021 and June 2023 to accomplish this. Inclusion criteria for this study included patients who had a single proximal Ureteral stone (between the pelvi ureteric junction and the upper border of the sacroiliac joint) measuring 15-20 mm in diameter.\n\nPatients were randomly allocated to receive either TPLU, RURS, or Minin-perc Antegrade URS, with a 1:1:1 allocation ratio. After providing informed permission, the patients were randomly assigned to one of three groups: Group I (35 patients treated with TPLU), Group II (35 patients treated with RURS), and Group III (35 patients not treated with either TPLU or RURS) (Included 35 patients who were treated by Mini-perc Antegrade URS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '26 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults patients\n* large proximal ureteral stones(1.5-2 cm)\n\nExclusion Criteria:\n\n* larger stones\n* multiple stones\n* bleeding tendency\n* active UTI\n* distal stricture'}, 'identificationModule': {'nctId': 'NCT06199518', 'briefTitle': 'Minimally Invasive Techniques for Treating Large Proximal Ureteral Stones', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparison of Laparoscopic Ureterolithotomy, Retrograde Flexible Ureteroscopy, and Mini- Percutaneous Antegrade Ureteroscopic Lithotripsy for the Management of Large Proximal Ureteral Stones (1.5-2 cm): A Prospective Randomized Trial.', 'orgStudyIdInfo': {'id': '34619/4/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP(A):transperitoneal laparoscopic ureterolithotomy (T-LUL)', 'description': 'extraction of proximal ureteral stones by laparoscopic surgery via transperitoneal approach', 'interventionNames': ['Procedure: transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP (B):retrograde flexible ureteroscopy (R-URS)', 'description': 'laser lithotripsy of proximal ureteral stones via flexible ureteroscopy retrograde', 'interventionNames': ['Procedure: transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP (C):Antegrade mini-percutaneous flexible ureteroscopy (A-URS)', 'description': 'laser lithotripsy of proximal ureteral stones via percutanous antegrade flexible ureteroscopy', 'interventionNames': ['Procedure: transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)']}], 'interventions': [{'name': 'transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)', 'type': 'PROCEDURE', 'description': 'extraction or fragmentation of large proximal ureteral stones via different minimally invasive procedures', 'armGroupLabels': ['GROUP (B):retrograde flexible ureteroscopy (R-URS)', 'GROUP (C):Antegrade mini-percutaneous flexible ureteroscopy (A-URS)', 'GROUP(A):transperitoneal laparoscopic ureterolithotomy (T-LUL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6620010', 'city': 'Tanta', 'state': 'Outside U.S./Canada', 'country': 'Egypt', 'facility': 'Urolgy Departement, Faculty of Medicine, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'faculty of medicine, Tanta, ElGeish street, Egypt', 'investigatorFullName': 'Ahmed Zoeir', 'investigatorAffiliation': 'Tanta University'}}}}