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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

150

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.3 years study duration

Study Start

First participant enrolled

March 2, 2015

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2015

Completed

6 months until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2019

Completed

Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

3.2 years

First QC Date

June 29, 2015

Last Update Submit

May 7, 2020

Conditions

Renal Stones

Keywords

Ureterorenoscopyextracorporeal shock waves lithotripsy

Outcome Measures

Primary Outcomes (1)

Number of patients stone free SFR 4
Patients with residual fragments \< 5 mm after treatment
1 month from treatment

Secondary Outcomes (7)

Number of patients stone free SFR 0
1 month from treatment
Number of patients stone free SFR 4
6 months after the treatment
Number of patients stone free SFR 0
6 months after the treatment
Number of patients stone free SFR 4
1 year after the treatment
Number of patients stone free SFR 0
1 year after the treatment
+2 more secondary outcomes

Study Arms (2)

RIRS (retrograde intrarenal surgery)

EXPERIMENTAL

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.

Procedure: RIRSDevice: Rigid and flexible ureteroscopeDevice: Holmium laserDevice: Basket for fragment removalProcedure: General or spinal anesthesiaDevice: X-ray

ESWL (extracorporeal shockwaves lithotripsy)

EXPERIMENTAL

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.

Procedure: ESWLDevice: LithotripterDrug: Intravenous pain medicationDevice: X-rayDevice: Ultrasound