To evaluate the effectiveness of RIRS (retrograde intrarenal surgery) and ESWL (extracorporeal shockwaves lithotripsy) in the treatment of renal stone ranging form 6 to 20 mm size.
European urological guidelines consider RIRS and ESWL the treatments of choice for renal stones \< 20 mm. RIRS is a endoscopic surgery which allows to rich the kidney from the ureter. A flexible ureteroscope is used for these kind of procedure. Through this device a laser fiber (Holmium laser) is used to treat the stones. After that, small fragments can be removed with a basket. In some cases, according to intraoperative findings, a ureteral stent can be push in the kidney to help the drainage of the kidney. ESWL is a procedure which allows to treat the stones by shock waves generated by a specific machine which work in direct contact with the skin of the patients (extracorporeal). Shockwaves pass all the tissues and finally reach the stones. Such energy allows to break the stones in small fragments, that wll be spontaneously passed by the patients. Specific parameters of these treatments are discussed in "Arms and Interventions". Many studies demonstrated high success rate of RIRS and this technique is becoming more and more adopt. One study demonstrated better outcomes of RIRS versus ESWL, but only for renal stones located in the inferior calices and smaller then 10 mm. There are not other studies comparing the two procedures and there are not proofs that RIRS ensures better outcomes for other renal stones (neither for size nor for location).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Urology, University of Turin
Turin, Italy
Number of patients stone free SFR 4
Patients with residual fragments \< 5 mm after treatment
Time frame: 1 month from treatment
Number of patients stone free SFR 0
Patients with no residual fragments after treatment
Time frame: 1 month from treatment
Number of patients stone free SFR 4
Patients with residual fragments \< 5 mm after treatment
Time frame: 6 months after the treatment
Number of patients stone free SFR 0
Patients with no residual fragments after treatment
Time frame: 6 months after the treatment
Number of patients stone free SFR 4
Patients with residual fragments \< 5 mm after treatment
Time frame: 1 year after the treatment
Number of patients stone free SFR 0
Patients with no residual fragments after treatment
Time frame: 1 year after the treatment
rate of complications
number of complications after treatment
Time frame: within 1 month form treatment
rate of further treatment needed
number of retreatment
Time frame: within 1 year
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If required by the patient
To focus the stone
To focus the stone