Effect of Emergency Urinary Drainage on Subsequent PCNL Outcomes in Obstructive Urosepsis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeni-Suef University
About this trial
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.
This 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Presence of renal or proximal ureteral stones.
Presentation with urosepsis secondary to obstructive urolithiasis.
Emergency urinary decompression performed by either retrograde ureteral stent (Double-J stent) or percutaneous nephrostomy (PCN).
Disqualifiers
Congenital renal anomalies (e.g., horseshoe kidney, ectopic kidney).
Pregnancy.
Uncorrectable coagulopathy or bleeding disorders.
Active, uncontrolled urinary tract infection at the time of definitive PCNL.
Trial design
Design model
Parallel
Treatments tested in this trial
Retrograde Ureteral Stenting followed by PCNL
Procedure/SurgeryEmergency 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.
Percutaneous Nephrostomy followed by PCNL
Procedure/SurgeryEmergency decompression via ultrasound- and/or 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Group A: Retrograde Ureteral Stent (RUS)Active comparator 1 intervention
Group B: Group B: Percutaneous Nephrostomy (PCN)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 to 4 weeks postoperativelySecondary outcomes
1
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.
Time frame
Within 30 days postoperativelySponsors and contacts
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Source ClinicalTrials.gov