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RIRS With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini PCNLfor Kidney Stones

RIRS With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini PCNLfor Kidney Stones

Recruiting
18-80 years
All
Phase N/A

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Overview

The goal of this observational study is to compare the safety and efficacy between RIRS with tip flexible pressure-controlling ureteral access sheath and mini percutaneous nephrolithotripsy(PCNL) for the treatment of 2-3-cm kidney stones.

Description

Retrograde Intrarenal Stone Surgery (RIRS) has become one of the most common treatments for renal stones. The development of ureteral access sheath (UAS) is a significant advance in RIRS. In recent years, various improvements have been made to UAS, especially the emergence of a suction UAS and a tip flexible UAS. Using the advantages of suction and tip flexible technology, our team developed a tip flexible pressure-controlling UAS, which significantly improves the safety and effectiveness of RIRS. However, the current guidelines can recommend the indication of RIRS in kidney stones less than 2cm, and percutaneous nephrolithotomy(PCNL) is still preferred for kidney stones larger than 2 cm. Therefore, this study is the first to compare the safety and efficacy between RIRS with tip flexible pressure-controlling UAS and mini PCNL in the treatment of 2 to 3 cm kidney stones.

Eligibility

Inclusion Criteria:

  • Adults aged ≥ 18 years
  • American Society of Anesthesiology score 1-2
  • Kidney stone diameter of 2-3 cm confirmed by CT
  • Capable of giving written informed consent, which includes adherence with the requirements of the trial

Exclusion Criteria:

  • Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit)
  • Patients with uncontrolled UTI
  • Patients with health or other factors that are absolute contraindications to RIRS or PCNL .Patients unable to understand or complete trial documentation.

Study details
    Kidney Stone

NCT06209931

The Affiliated Ganzhou Hospital of Nanchang University

26 January 2024

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