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Modified Mini-PCNL Versus Standard PCNL for Complex Kidney Stones

RecruitingNAAges 18 Years - 70 YearsAllThe First Affiliated Hospital of Guangzhou Medica…
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In plain words

What the trial is, and whether it could suit you

Kidney stones that are large or complex are often treated with percutaneous nephrolithotomy, also called PCNL. Standard PCNL uses a larger access tract and is effective for removing complex kidney stones, but it may be associated with more bleeding, pain, and recovery burden. Modified mini-PCNL uses a smaller access tract and may reduce surgical trauma while maintaining a similar stone clearance rate. This multicenter randomized trial will compare modified mini-PCNL using a 20 Fr access sheath with standard PCNL using a 24 Fr access sheath in adults with complex renal stones. About 1,380 participants from 8 urology centers will be randomly assigned to receive one of the two procedures. The main purpose of the study is to determine whether modified mini-PCNL is not worse than standard PCNL in achieving stone-free status shortly after surgery. Stone-free status will be assessed by low-dos

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adults aged ≥18 years. 2. Serum creatinine ≤133 μmol/L. 3. American Society of Anesthesiologists (ASA) physical status classification I-III. 4. S.T.O.N.E. score ≥8. 5. Complex renal stones confirmed by noncontrast computed tomography, including stone surface area \>1500 mm², multiple calyceal stones, partial or complete staghorn calculi, or complex anatomical conditions. 6. Patients who provide written informed consent and agree to undergo either modified mini-percutaneous nephrolithotomy or standard percutaneous nephrolithotomy. Exclusion Criteria: 1. Solitary kidney. 2. Morbid obesity (body mass index ≥35 kg/m²). 3. Previous renal transplantation or urinary diversion. 4. Congenital abnormalities of the urinary tract. 5. Pregnancy. 6. Uncorrected coagulopathy. 7. Active urinary tract infection.
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What it tests

  • 20 Fr Modified Mini Percutaneous Nephrolithotomy
  • 24 Fr Standard Percutaneous Nephrolithotomy
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Where

1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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