Kidney Stone, Urosepsis
Conditions
Brief summary
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.
Detailed description
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. Following 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.
Interventions
PROCEDURERetrograde 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.
PROCEDUREPercutaneous Nephrostomy followed by PCNL
Emergency 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.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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). * Patients scheduled for definitive stone management via percutaneous nephrolithotomy (PCNL) after clinical stabilization and infection resolution. * Written informed consent obtained prior to enrollment.
Exclusion criteria
* 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. * Severe cardiopulmonary comorbidities rendering the patient unfit for surgery or general anesthesia. * Patients managed definitively by other modalities (e.g., ureteroscopy or ESWL alone).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-Free Rate (SFR) after PCNL | 2 to 4 weeks postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Fever or Recurrent Sepsis | Within 30 days postoperatively | Percentage of patients developing postoperative fever (body temperature ≥ 38.0°C) or systemic signs of recurrent urosepsis following PCNL. |
Countries
Egypt
Contacts
CONTACTMahmoud Abdallah Mahmoud, lecturer
Outcome results
None listed