Evaluation of the Effectiveness of Intrarenal Dioxidine Metaphylaxis for Preventing Recurrence of Infection Stones After Percutaneous Nephrolithotripsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Recurrence of infection-related kidney stones
研究概览
简要总结
Kidney stone recurrence, particularly infection-related stones, remains a significant clinical problem after percutaneous nephrolithotripsy (PCNL). Bacterial colonization and persistent infection are recognized contributors to stone recurrence.
This study evaluates the effectiveness of intrarenal dioxidine instillation as a metaphylactic measure to reduce recurrence of infection-related kidney stones following PCNL. Patients undergoing PCNL will receive standard treatment, with or without adjunctive intrarenal dioxidine administration. The study aims to assess whether this approach reduces stone recurrence and infection-related complications.
详细描述
Infection-related kidney stones are associated with urease-producing bacteria and carry a high risk of recurrence even after successful surgical removal. Percutaneous nephrolithotripsy (PCNL) is the standard treatment for large or complex renal calculi; however, residual infection and bacterial biofilms may contribute to recurrent stone formation.
Metaphylaxis strategies targeting infection control may reduce recurrence rates. Dioxidine is an antimicrobial agent with broad-spectrum activity against gram-positive and gram-negative bacteria and has been used locally in urological practice. Intrarenal instillation may help reduce bacterial colonization in the collecting system.
The purpose of this study is to evaluate the clinical effectiveness and safety of intrarenal dioxidine instillation as a metaphylactic intervention after PCNL for infection-related kidney stones. Outcomes include stone recurrence, urinary tract infection rates, and postoperative complications. The results may help define improved metaphylaxis strategies for patients with infection-related nephrolithiasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Patients undergoing percutaneous nephrolithotripsy (PCNL)
- •Infection-related kidney stones
- •Ability to provide written informed consent
排除标准
- •Age <18 years
- •Pregnancy or breastfeeding
- •Known hypersensitivity to dioxidine
- •Severe renal insufficiency or end-stage renal disease
- •Severe comorbid conditions that preclude participation
研究组 & 干预措施
Intrarenal Dioxidine Group
Participants undergo PCNL followed by intrarenal instillation of dioxidine to prevent infection-related stone recurrence.
干预措施: Dioxidine (Drug)
Intrarenal Dioxidine Group
Participants undergo PCNL followed by intrarenal instillation of dioxidine to prevent infection-related stone recurrence.
干预措施: Percutaneous Nephrolithotripsy (PCNL) (Procedure)
Standard Treatment Group
Participants undergo standard PCNL without adjunctive dioxidine.
干预措施: Percutaneous Nephrolithotripsy (PCNL) (Procedure)
结局指标
主要结局
Recurrence of infection-related kidney stones
时间窗: 12 months post-PCNL
Proportion of patients with recurrent infection-related kidney stones within 12 months after percutaneous nephrolithotripsy, assessed by imaging studies (ultrasound or CT) and clinical evaluation.
次要结局
未报告次要终点
研究者
Talgat A. Imzharov
Principal Investigator
West Kazakhstan Marat Ospanov Medical University