Kidney Stone
Conditions
Brief summary
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.
Detailed 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.
Interventions
PROCEDURERIRS
RIRS with tip flexible pressure-controlling ureteral access sheath versus mini PCNL for the treatment of 2-3-cm kidney stones
Sponsors
The Affiliated Ganzhou Hospital of Nanchang University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate stone-free rate | Postoperative day 1-7 | No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1-7 are defined as stone free. |
| Stone-free rate at 1 months | Postoperative 1 month | No residual stone or stone fragments less than 2 mm on kidney, ureter, and bladder at 1 months are defined as stone free. |
| Complications up to 3 months post | Postoperative 3 month | — |
| Operation time | the time from the insertion of the suction sheath and renal puncture to the end of the operation,assessed up to 90 minutes. | The operation time of RIRS and mini PCNL was defined as the time from the insertion of the suction sheath and renal puncture to the end of the operation |
Countries
China
Contacts
Primary ContactXin Huang, M.D.
Outcome results
None listed