Effect of Emergency Urinary Drainage Method on Subsequent Percutaneous Nephrolithotomy Outcomes in Patients With Obstructive Urosepsis: A Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Stone-Free Rate (SFR) after PCNL
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Group A: Retrograde Ureteral Stent (RUS)
Patients presenting with obstructive urosepsis who undergo initial emergency urinary decompression via retrograde ureteral stent (RUS / Double J stent) insertion, followed by definitive percutaneous nephrolithotomy (PCNL) after sepsis resolution and urine culture sterilization.
干预措施: Retrograde Ureteral Stenting followed by PCNL (Procedure)
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.
干预措施: Percutaneous Nephrostomy followed by PCNL (Procedure)
结局指标
主要结局
Stone-Free Rate (SFR) after PCNL
时间窗: 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.
次要结局
- Incidence of Postoperative Fever or Recurrent Sepsis(Within 30 days postoperatively)
研究者
Mahmoud Abdallah
lecturer of urology
Beni-Suef University