This study evaluates the safety and efficacy of the novel tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi using a prospective, randomized multicentre trial design. Half of participants will receive retrograde intrarenal surgery using the tip-flexible semi-rigid ureterorenoscope, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscope.
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, some limitations still remain. Poor maneuverability, extra costs for the ureteral access sheath, and high device vulnerability still preclude flexible ureteroscopy from wider distribution. Recently, the investigators present a novel ureterorenoscope, which is composed of a retractable rigid sheath and a semi-rigid ureteroscope with a flexible part on the tip. When the flexible tip of the inner shaft maintains within the sheath, working in the "rigid mode", the tip-flexible semi-rigid ureterorenoscope is capable of passing either the orifice or the physiological tortuosity of the ureter with ease. When the inner shaft is extended beyond the sheath, the endoscope is switched to the "flexible mode", capable of performing an intrarenal approach. This endoscope integrates the classic semi-rigid and flexible ureteroscope both structurally and functionally, and has been approved for clinical application by the China Food and Drug Administration. In this study, transverse comparison is designed to evaluate the safety and efficacy of the tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
280
Ureteroscopy will be conducted using the tip-flexible semi-rigid ureterorenoscope to treat renal calculi. Holmium laser and basket can be used to perform the technique.
Ureteroscopy will be conducted using the classic flexible ureteroscope (Flex x2 STORZ, Germany) to treat renal calculi. Holmium laser and basket can be used to perform the technique.
Stone clearance
Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group \*100%
Time frame: 12 weeks post-operatively
Stone clearance
Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group \*100%
Time frame: One day post-operatively
Complication rates
Number of participants undergo tf-URS or f-URS surgeries suffer complications associated with the surgery (i.e. painess(NRS≥4), hematuria, T≥38℃, serum WBC≥12×〖10〗\^9/L ,serum WBC\<4×〖10〗\^9/L, perforation, etc.)/Total number of participants in each group \*100%
Time frame: Within 12 weeks after surgery
Endoscope deflection loss rates
Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with deflection loss\>10%/Total number of ureterorenoscope or ureterosocpe used \*100%
Time frame: intraoperative
Endoscope Leakage rates
Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with leakage of the working channel or the outer shaft/times of the ureterorenoscope or ureterosocpe used \*100%
Time frame: intraoperative
Endoscope black dots rates
Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with black dots on endoscopic images/times of ureterorenoscope or ureterosocpe used \*100%
Time frame: intraoperative
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