Renal Stones
Conditions
Keywords
Ureterorenoscopy, extracorporeal shock waves lithotripsy
Brief summary
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.
Detailed description
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).
Interventions
Treatment by ureterorenoscopy (RIRS) and laser lithotripsy
Treatment by extracorporeal shock waves lithotripsy
If required by the patient
To focus the stone
To focus the stone
Sponsors
Study design
Eligibility
Inclusion criteria
* renal stone measuring 6 to 20 mm * signing informed consent * WHO performance status 0-2
Exclusion criteria
* Other stone \>5 mm * concomitant ureteral stones * BMI \> 35 * severe coagulopathy * impossibility to sign informed consent * pregnancy * age \< 18 years old or \> 85
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients stone free SFR 4 | 1 month from treatment | Patients with residual fragments \< 5 mm after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients stone free SFR 0 | 1 month from treatment | Patients with no residual fragments after treatment |
| Number of patients stone free SFR 4 | 6 months after the treatment | Patients with residual fragments \< 5 mm after treatment |
| rate of complications | within 1 month form treatment | number of complications after treatment |
| rate of further treatment needed | within 1 year | number of retreatment |
Countries
Italy