NCT02645058

RIRS Versus ESWL for the Treatment of Renal Stones

Retrograde Intrarenal Surgery (RIRS) Versus Extracorporeal Shock Waves Lithotripsy (ESWL) for the Treatment of Renal Stones Measuring 6-20 mm: A Prospective Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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).

Conditions

• Renal Stones

Interventions

Type	Name	Description
PROCEDURE	RIRS	Treatment by ureterorenoscopy (RIRS) and laser lithotripsy
PROCEDURE	ESWL	Treatment by extracorporeal shock waves lithotripsy
DEVICE	Rigid and flexible ureteroscope
DEVICE	Lithotripter
DEVICE	Holmium laser
DEVICE	Basket for fragment removal
PROCEDURE	General or spinal anesthesia
DRUG	Intravenous pain medication	If required by the patient
DEVICE	X-ray	To focus the stone
DEVICE	Ultrasound	To focus the stone

Timeline

• Start date: 2015-03-02
• Primary completion: 2018-05-30
• Completion: 2019-06-19
• First posted: 2016-01-01
• Last updated: 2020-05-11

Locations

1 site across 1 country: Italy