[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656411":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":27,"studyPopulation":18,"armGroups":28,"interventions":40,"overallOfficials":18,"centralContacts":50,"locations":56,"responsibleParty":76,"collaborators":18,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":18,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":18,"enrollmentInfo":89,"targetDuration":18,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":18,"overallStatus":59,"whyStopped":18,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Beni-Suef University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Stone-Free Rate (SFR) after PCNL","Percentage of patients achieving stone-free status, defined as the complete absence of residual stone fragments or presence of clinically insignificant residual fragments ≤ 2 mm, assessed via non-contrast CT or ultrasound.","2 to 4 weeks postoperatively",[14],{"measure":15,"description":16,"timeFrame":17},"Incidence of Postoperative Fever or Recurrent Sepsis","Percentage of patients developing postoperative fever (body temperature ≥ 38.0°C) or systemic signs of recurrent urosepsis following PCNL.","Within 30 days postoperatively",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":25},"SINGLE",[26],"OUTCOMES_ASSESSOR","Patients presenting to the emergency department with obstructive upper urinary tract stones and urosepsis will be prospectively enrolled. Initial emergency management includes hemodynamic resuscitation, broad-spectrum intravenous antibiotic therapy, and emergency decompression of the collecting system using either retrograde ureteral stent (RUS) insertion or percutaneous nephrostomy (PCN) based on surgeon judgment and clinical feasibility.\n\nFollowing complete clinical resolution of sepsis, normalization of inflammatory markers, and confirmation of a sterile urine culture, patients will undergo definitive percutaneous nephrolithotomy (PCNL) under general anesthesia. Operative parameters including access technique, dilation, fragmentation method, operative time, and hemoglobin drop will be recorded. Postoperatively, complications will be graded according to the Clavien-Dindo classification system. Stone-free status (defined as the absence of residual fragments or fragments ≤ 4 mm) will be assessed at 2-4 weeks postoperatively using non-contrast computed tomography (NCCT) or ultrasonography.",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"Group A: Retrograde Ureteral Stent (RUS)","ACTIVE_COMPARATOR","Patients presenting with obstructive urosepsis who undergo initial emergency urinary decompression via retrograde ureteral stent (RUS \u002F Double J stent) insertion, followed by definitive percutaneous nephrolithotomy (PCNL) after sepsis resolution and urine culture sterilization.",[34],"Procedure: Retrograde Ureteral Stenting followed by PCNL",{"label":36,"type":31,"description":37,"interventionNames":38},"Group B: Percutaneous Nephrostomy (PCN)","Patients presenting with obstructive urosepsis who undergo initial emergency urinary decompression via percutaneous nephrostomy (PCN) tube insertion, followed by definitive percutaneous nephrolithotomy (PCNL) after sepsis resolution and urine culture sterilization.",[39],"Procedure: Percutaneous Nephrostomy followed by PCNL",[41,46],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":18},"PROCEDURE","Retrograde Ureteral Stenting followed by PCNL","Emergency decompression via retrograde ureteral stent (Double-J stent) placement under fluoroscopic guidance, along with intravenous antibiotic therapy and resuscitation. Once sepsis resolves, inflammatory markers normalize, and urine culture becomes sterile, definitive percutaneous nephrolithotomy (PCNL) is performed.",[30],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":18},"Percutaneous Nephrostomy followed by PCNL","Emergency decompression via ultrasound- and\u002For fluoroscopy-guided percutaneous nephrostomy (PCN) tube insertion, combined with intravenous antibiotics and resuscitation. After complete resolution of sepsis, normalization of inflammatory parameters, and confirmation of sterile urine, definitive percutaneous nephrolithotomy (PCNL) is performed.",[36],[51],{"name":52,"role":53,"phone":54,"phoneExt":18,"email":55},"Mahmoud Abdallah Mahmoud, lecturer","CONTACT","01155361979","mahmoud.abdalla@med.bsu.edu.eg",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Faculty of Medicine, Beni-Suef University","RECRUITING","Banī Suwayf","Beni Suweif Governorate","62511","Egypt","EG",{"type":66,"coordinates":67},"Point",[68,69],31.09785,29.07441,{"lat":69,"lon":68},[72],{"name":73,"role":53,"phone":74,"phoneExt":18,"email":75},"doaa mahmoud khalil, assisstant professor","01152091011","drm_abdallah_88@yahoo.com",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Mahmoud Abdallah","lecturer of urology","100656411","effect-of-emergency-urinary-drainage-on-subsequent-pcnl-outcomes-in-obstructive-urosepsis-100656411",false,"NCT07826325","Effect of Emergency Urinary Drainage on Subsequent PCNL Outcomes in Obstructive Urosepsis","Effect of Emergency Urinary Drainage Method on Subsequent Percutaneous Nephrolithotomy Outcomes in Patients With Obstructive Urosepsis: A Prospective Comparative Study","Inclusion Criteria:\n\n* Age 18 years or older.\n* Presence of renal or proximal ureteral stones.\n* Presentation with urosepsis secondary to obstructive urolithiasis.\n* Emergency urinary decompression performed by either retrograde ureteral stent (Double-J stent) or percutaneous nephrostomy (PCN).\n* Patients scheduled for definitive stone management via percutaneous nephrolithotomy (PCNL) after clinical stabilization and infection resolution.\n* Written informed consent obtained prior to enrollment.\n\nExclusion Criteria:\n\n* Congenital renal anomalies (e.g., horseshoe kidney, ectopic kidney).\n* Pregnancy.\n* Uncorrectable coagulopathy or bleeding disorders.\n* Active, uncontrolled urinary tract infection at the time of definitive PCNL.\n* Severe cardiopulmonary comorbidities rendering the patient unfit for surgery or general anesthesia.\n* Patients managed definitively by other modalities (e.g., ureteroscopy or ESWL alone).","ALL","18 Years",{"count":90,"type":91},100,"ESTIMATED","INTERVENTIONAL",[94],"NA","Obstructive urolithiasis complicated by urosepsis is a life-threatening medical emergency requiring urgent urinary tract decompression. Emergency drainage is typically achieved by either retrograde ureteral stent (RUS) insertion or percutaneous nephrostomy (PCN). Following clinical stabilization and resolution of infection, percutaneous nephrolithotomy (PCNL) is commonly performed as definitive stone treatment.\n\nThis prospective comparative study aims to evaluate and compare the outcomes of subsequent PCNL between patients who underwent emergency drainage via retrograde ureteral stent and those who underwent percutaneous nephrostomy. The main outcomes to be compared include stone-free rates, operative time, blood loss, postoperative complications, length of hospital stay, and the need for auxiliary procedures.",[97,98],"Urosepsis","Kidney Stone","2026-09-13",{"date":101,"type":102},"2026-09-17","ACTUAL",{"date":104,"type":91},"2026-10",{"date":106,"type":91},"2028-06",{"name":5,"class":6},1]