[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640160":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":29,"responsibleParty":55,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":32,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Beni-Suef University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vacuum-Assisted Mini-Percutaneous Cystolithotripsy","EXPERIMENTAL","Participants randomized to this arm will undergo vacuum-assisted mini-percutaneous cystolithotripsy under general anesthesia using suprapubic percutaneous bladder access and a suction-assisted mini sheath. Ho:YAG laser lithotripsy will be used for stone fragmentation, with suction-assisted evacuation of stone dust and fragments.",[13],"Procedure: Vacuum-Assisted Mini-Percutaneous Cystolithotripsy",{"label":15,"type":16,"description":17,"interventionNames":18},"Transurethral Cystolithotripsy","ACTIVE_COMPARATOR","Participants randomized to this arm will undergo standard transurethral cystolithotripsy under general anesthesia using the smallest appropriate pediatric semi-rigid ureteroscope. Ho:YAG laser lithotripsy will be used for stone fragmentation, with fragment evacuation through the transurethral route",[19],"Procedure: Transurethral Cystolithotripsy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Surgical treatment of pediatric bladder stones using suprapubic mini-percutaneous bladder access, a suction-assisted mini sheath, and Ho:YAG laser lithotripsy for stone fragmentation and evacuation",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Standard transurethral endoscopic treatment of pediatric bladder stones using an appropriate pediatric semi-rigid ureteroscope with Ho:YAG laser lithotripsy and transurethral fragment evacuation",[15],[30],{"facility":31,"status":32,"city":33,"state":34,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Urology Department - Beni-Suef University Hospitals","RECRUITING","Banī Suwayf","Beni Suweif Governorate","Egypt","EG",{"type":38,"coordinates":39},"Point",[40,41],31.09785,29.07441,{"lat":41,"lon":40},[44,49,53],{"name":45,"role":46,"phone":47,"phoneExt":25,"email":48},"Hany Fathy Badawy, MD","CONTACT","+201149525028","Hanyfathy86@gmail.com",{"name":50,"role":46,"phone":51,"phoneExt":25,"email":52},"Mahmoud Abdallah, Md","+20 11 55361979","Drhanyfathy86@gmail.com",{"name":45,"role":54,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":45,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Lecturer of Urology, Faculty of Medicine, Beni-Suef University","100640160","vacuum-assisted-mini-percutaneous-versus-transurethral-cystolithotripsy-in-pediatric-bladder-stones-100640160",false,"NCT07614880","Vacuum-Assisted Mini-Percutaneous Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones","Vacuum-Assisted Mini-Percutaneous Cystolithotomy Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Study","VAMPCL-Ped","Inclusion Criteria:\n\n* Children aged 2 to 14 years.\n* Diagnosis of bladder stone or stones measuring 10-30 mm in maximum cumulative diameter, confirmed by ultrasound.\n* Normal upper urinary tract.\n* Fit for general anesthesia.\n* Written informed consent obtained from parents or legal guardians.\n\nExclusion Criteria:\n\n* Known urethral stricture or posterior urethral valves.\n* Active urinary tract infection at the time of surgery.\n* Coagulopathy or uncorrected bleeding disorder.\n* Previous open bladder surgery.\n* Any anatomical or clinical condition that, in the investigator's judgment, precludes safe endoscopic or percutaneous cystolithotripsy.","ALL","2 Years","14 Years",{"count":69,"type":70},40,"ESTIMATED","INTERVENTIONAL",[73],"NA","This prospective randomized pilot study will compare vacuum-assisted mini-percutaneous cystolithotripsy with standard transurethral cystolithotripsy for the treatment of bladder stones in children. Forty children aged 2 to 14 years with bladder stone(s) measuring 10 -30 mm will be randomly assigned to one of two surgical approaches. The vacuum-assisted mini-percutaneous group will undergo suprapubic percutaneous access using a mini sheath with suction-assisted fragment evacuation, while the transurethral group will undergo standard transurethral cystolithotripsy. The primary outcome will be total operative time. Secondary outcomes will include stone-free rate ,lithotripsy time and fragment clearance time, urethral mucosal injury, postoperative hematuria, fever, urinary tract infection, sepsis, urinary retention, urinary leakage from the suprapubic tract, catheterization time, hospital stay, postoperative pain, analgesic requirement, need for auxiliary procedures or conversion, and recurrence or urethral stricture-related symptoms during follow-up.",[76,77,78],"Pediatric Bladder Stones","Bladder Calculi","Pediatric Urolithiasis",[80,81,82,83],"Pediatric bladder stones","Mini-percutaneous cystolithotripsy","Vacuum-assisted cystolithotripsy","Ho:YAG laser lithotripsy","2026-05-28",{"date":86,"type":87},"2026-06-01","ACTUAL",{"date":89,"type":87},"2026-03-04",{"date":91,"type":70},"2028-03",{"name":5,"class":6},1]