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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02645058
Enrollment
150
Registered
2016-01-01
Start date
2015-03-02
Completion date
2019-06-19
Last updated
2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Stones

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

PROCEDURERIRS

Treatment by ureterorenoscopy (RIRS) and laser lithotripsy

PROCEDUREESWL

Treatment by extracorporeal shock waves lithotripsy

DEVICERigid and flexible ureteroscope
DEVICEBasket for fragment removal
PROCEDUREGeneral or spinal anesthesia
DRUGIntravenous pain medication

If required by the patient

DEVICEX-ray

To focus the stone

DEVICEUltrasound

To focus the stone

Sponsors

University of Turin, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Number of patients stone free SFR 41 month from treatmentPatients with residual fragments \< 5 mm after treatment

Secondary

MeasureTime frameDescription
Number of patients stone free SFR 01 month from treatmentPatients with no residual fragments after treatment
Number of patients stone free SFR 46 months after the treatmentPatients with residual fragments \< 5 mm after treatment
rate of complicationswithin 1 month form treatmentnumber of complications after treatment
rate of further treatment neededwithin 1 yearnumber of retreatment

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026