Study Results
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Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2015-03-02
2019-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RIRS (retrograde intrarenal surgery)
In the first arm (RIRS) the patients will be treated by a standard retrograde ureterorenoscopy and Holmium laser lithotripsy. Preoperative exams will be abdomen ultrasound and Xray (CT in case of stones \> 15 mm), urine analysis and culture (according to all the more recent guidelines). Surgeries will be performed under general or spinal anesthesia, according to anesthesiologist evaluation. According with standard technique, ureteroscopy will be performed using both rigid and flexible ureteroscope. Lithotripsy will be performed by Holmium laser. Major stone fragments will be removed at the end of the procedure. Finally a double J ureteral stent will be push in specific cases depending on intraoperative findings (length of the procedure, macroscopic view of the ureter, residual stones etc.). RIRS will be an outpatients procedure with an hospital stay \<23 hours. Some patients may require a longer hospital stay due to specific pre-operative diseases or intra/post-operative events.
RIRS
Treatment by ureterorenoscopy (RIRS) and laser lithotripsy
Rigid and flexible ureteroscope
Holmium laser
Basket for fragment removal
General or spinal anesthesia
X-ray
To focus the stone
ESWL (extracorporeal shockwaves lithotripsy)
In the second arm (ESWL) the patients will be treated by a standard extracorporeal shock waves lithotripsy (ESWL). Preoperative exams will be the same as first arm. No general or spinal anaesthesia will be used, but just intravenous medications if required. Ultrasound and/or X-Ray will be used to locate the stone. Power and number of shock waves will consist in 20-24 KV and 3000-3500 sw respectively, according to individual tolerance. ESWL will be an outpatients procedure with an hospital stay \<23 hours. Some patients may require a longer hospital stay due to specific pre-operative diseases or intra/post-operative events.
ESWL
Treatment by extracorporeal shock waves lithotripsy
Lithotripter
Intravenous pain medication
If required by the patient
X-ray
To focus the stone
Ultrasound
To focus the stone
Interventions
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RIRS
Treatment by ureterorenoscopy (RIRS) and laser lithotripsy
ESWL
Treatment by extracorporeal shock waves lithotripsy
Rigid and flexible ureteroscope
Lithotripter
Holmium laser
Basket for fragment removal
General or spinal anesthesia
Intravenous pain medication
If required by the patient
X-ray
To focus the stone
Ultrasound
To focus the stone
Eligibility Criteria
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Inclusion Criteria
* signing informed consent
* WHO performance status 0-2
Exclusion Criteria
* concomitant ureteral stones
* BMI \> 35
* severe coagulopathy
* impossibility to sign informed consent
* pregnancy
* age \< 18 years old or \> 85
18 Years
85 Years
ALL
Yes
Sponsors
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University of Turin, Italy
OTHER
Responsible Party
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Ettore Dalmasso
Doctor
Principal Investigators
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Andrea Bosio, Medicine
Role: PRINCIPAL_INVESTIGATOR
Urology, University of Turin
Locations
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Urology, University of Turin
Turin, , Italy
Countries
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References
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Bosio A, Alessandria E, Dalmasso E, Agosti S, Vitiello F, Vercelli E, Bisconti A, Gontero P. Flexible Ureterorenoscopy Versus Shockwave Lithotripsy for Kidney Stones </=2 cm: A Randomized Controlled Trial. Eur Urol Focus. 2022 Nov;8(6):1816-1822. doi: 10.1016/j.euf.2022.04.004. Epub 2022 Apr 22.
Other Identifiers
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0016589
Identifier Type: -
Identifier Source: org_study_id
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