Renal Calculi Clinical Trial
Official title:
Safety and Efficacy of Suctioning Flexible Ureteroscopy With Automatic Control of Renal Pelvic Pressure : A Clinical Randomized,Controlled Study
This study evaluates the safety and efficacy of the suctioning flexible ureteroscopy(SF-URS) with automatic control of renal pelvic pressure for the treatment of upper urinary calculi using a prospective, randomized design. Half of participants will receive suctioning flexible ureteroscopy with automatic control of renal pelvic pressure, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscopy.
Retrograde intrarenal surgery using flexible ureteroscope has become the first-line
treatment for renal calculi < 3.0 cm and is recommended by the European Association of
Urology due to its minimally-invasive nature and satisfactory result.
However, high perfusion rate leads to renal pelvic pressure increase, resulting in
absorption of liquid, bacteria, and endotoxin into blood, followed by short-term
complications such as systemic inflammatory response syndrome(SIRS , 8.1%), sepsis (0-4.5%),
renal pelvic and ureteral tumor spread, and long-term complication of renal function
impairment. Currently the commonly used flexible ureteroscope sheath (ureteral access
sheath, UAS) reduces the renal pelvic pressure to a certain extent, but still can not
control and monitor the renal pelvic pressure to reduce the incidence of complications,
which, limit the clinical application of ureteroscopy.
Recently, the investigators present a novel technique of SF-URS with automatic control of
renal pelvic pressure. In this study, transverse comparison is designed to evaluate the
safety and efficacy of the suctioning flexible ureteroscopy with automatic control of renal
pelvic pressure for the treatment of renal calculi.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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