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Prospective randomized controlled study of bendable negative pressure suction sheath combined with flexible ureteroscopy versus percutaneous nephrolithotomy in the treatment of 2-3 cm renal stones

Prospective randomized controlled study of bendable negative pressure suction sheath combined with flexible ureteroscopy versus percutaneous nephrolithotomy in the treatment of 2-3 cm renal stones

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089384
Enrollment
Unknown
Registered
2024-09-06
Start date
2024-09-10
Completion date
Unknown
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

urinary stones

Interventions

Test group:Flexible negative pressure suction sheath combined with flexible ureteral scope for treatment of 2-3cm kidney stones
Control group:Percutaneous nephrolithotomy treatment of 2-3cm kidney stones

Sponsors

Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age 18 years or above; (2) Single, multiple renal stones and/or pelvic-ureteral junction stones with a total CT scan diameter of 2-3 cm; (3) Able to complete the study as required by the trial protocol; (4) Be informed about the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Congenital or structural anomalies of the kidney: horseshoe kidney, sponge kidney, polycystic kidney, ectopic kidney, etc; (2) History of previous open surgery on the affected kidney; (3) Patients with uncontrolled urinary tract infection; (4) Patients unable to understand or cooperate in completing the experimental protocol; (5) Patients with absolute contraindications to RIRS and/or PCNL surgery due to health or other factors.

Design outcomes

Primary

MeasureTime frame
Final stone-free rate;

Secondary

MeasureTime frame
Immediate postoperative SFR;Surgical time;SFR 1 month postoperatively;Intraoperative complications;Elevated blood creatinine values 1-2 days postoperatively;Decreased haemoglobin values 1-2 days after surgery;Elevated PCT values 1-2 days after surgery;Elevated WBC values 1-2 days postoperatively;Days of hospitalisation;postoperative complication;Quality of life score;

Countries

China

Contacts

Public ContactJianxing Li

Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital

ljxa01048@btch.edu.cn+86 133 2116 9366

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026