Percutaneous Nephrolithotomy (PCNL), Urolithiasis
Conditions
Brief summary
The goal of this clinical trial is to introduce a novel multifunctional miniature endoscopic system, namely "Aircraft Nephroscope", for percutaneous nephrolithotomy (PCNL) to treat the patients with urolithiasis. The main questions it aims to answer are: 1. Is the "Aircraft Nephroscope" a safe and efficient instrument for PCNL? 2. What types of nephrocope the "Aircraft Nephroscope" is and what function does it have? Researchers will observe the surgical outcome through the stone-free rate and compliction rates. Participants will: 1. Undergo PCNL with "Aircraft Nephroscope" 2. Follow-up the stone-free rate for 2 weeks after surgery
Interventions
After all the preparations of the procedure, the operator could select the appropriate nephroscope based on the stone burden. It was feasible and efficient to use the F17 nephroscope for the removal of large and soft calculi through ultrasonic lithotripsy. If the stones were hard and large, it would be advisable to select the F12 nephroscope for stone removal through pneumatic lithotripsy or by using a laser fiber, and the negative pressure suction function could enhance efficiency. To minimize the wound size, it was advisable to select the F8 nephroscope for small stones and utilize its suction-evacuation function to extract the stones. For complex kidney stones, including multiple stones or staghorn stones, surgeons can choose from combinations of the F8 nephroscope, F12 nephroscope, and F17 nephroscope to completely remove the stones.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Serum creatinine (≤200 μmol/l); 2. American Society of Anesthesiology score of 1-3; 3. Agree to undergo PCNL with "Aircraft Nephroscope", provide written informed consent and adhere to the requirements of the trial.
Exclusion criteria
1. Patients with histories of renal transplant or urinary diversion; 2. patients with congenital abnormalities; 3. Pregnant patients; 4. Patients with uncorrected coagulopathy and 5. Patients with active urinary tract infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stone-free rate | From enrollment to the end of treatment at 2 weeks |
Countries
China