Metaphylaxis of Infected Kidney Stones After Percutaneous Nephrolithotripsy
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dioxidine, Percutaneous Nephrolithotripsy (PCNL).
- Who it may be relevant to
- Registry conditions: Kidney Calculi, Nephrolithiasis, Urinary Tract Infections. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kazakhstan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effectiveness of Intrarenal Dioxidine Metaphylaxis for Preventing Recurrence of Infection Stones After Percutaneous Nephrolithotripsy
Overview
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.
Detailed description
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.
Interventions
- Drug Dioxidine
Intrarenal instillation of dioxidine solution after PCNL to reduce bacterial colonization and prevent recurrence of infection-related stones. - Procedure Percutaneous Nephrolithotripsy (PCNL)
Standard percutaneous nephrolithotripsy procedure for removal of kidney stones.
Primary outcome measures
- Recurrence of infection-related kidney stones [Time frame: 12 months post-PCNL]
Eligibility criteria
Inclusion criteria
Age ≥18 years
Patients undergoing percutaneous nephrolithotripsy (PCNL)
Infection-related kidney stones
Ability to provide written informed consent
Exclusion criteria
Age <18 years
Pregnancy or breastfeeding
Known hypersensitivity to dioxidine
Severe renal insufficiency or end-stage renal disease
Severe comorbid conditions that preclude participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Kazakhstan · 1 center
- West Kazakhstan Marat Ospanov Medical University — Aqtöbe
Identifiers
NCT: NCT07393711 · Approval No. 11 (11.16/03) · EC Approval 11-16/03