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

Patrocinadores

Patrocinador principal: University of Turin, Italy

Fuente University of Turin, Italy
Resumen breve

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.

Descripción detallada

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).

Estado general Completed
Fecha de inicio March 2, 2015
Fecha de Terminación June 19, 2019
Fecha de finalización primaria May 30, 2018
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Number of patients stone free SFR 4 1 month from treatment
Resultado secundario
Medida Periodo de tiempo
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
rate of complications within 1 month form treatment
rate of further treatment needed within 1 year
Inscripción 150
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: RIRS

Descripción: Treatment by ureterorenoscopy (RIRS) and laser lithotripsy

Etiqueta de grupo de brazo: RIRS (retrograde intrarenal surgery)

Tipo de intervención: Procedure

Nombre de intervención: ESWL

Descripción: Treatment by extracorporeal shock waves lithotripsy

Etiqueta de grupo de brazo: ESWL (extracorporeal shockwaves lithotripsy)

Tipo de intervención: Device

Nombre de intervención: Rigid and flexible ureteroscope

Etiqueta de grupo de brazo: RIRS (retrograde intrarenal surgery)

Tipo de intervención: Device

Nombre de intervención: Lithotripter

Etiqueta de grupo de brazo: ESWL (extracorporeal shockwaves lithotripsy)

Tipo de intervención: Device

Nombre de intervención: Holmium laser

Etiqueta de grupo de brazo: RIRS (retrograde intrarenal surgery)

Tipo de intervención: Device

Nombre de intervención: Basket for fragment removal

Etiqueta de grupo de brazo: RIRS (retrograde intrarenal surgery)

Tipo de intervención: Procedure

Nombre de intervención: General or spinal anesthesia

Etiqueta de grupo de brazo: RIRS (retrograde intrarenal surgery)

Tipo de intervención: Drug

Nombre de intervención: Intravenous pain medication

Descripción: If required by the patient

Etiqueta de grupo de brazo: ESWL (extracorporeal shockwaves lithotripsy)

Tipo de intervención: Device

Nombre de intervención: X-ray

Descripción: To focus the stone

Tipo de intervención: Device

Nombre de intervención: Ultrasound

Descripción: To focus the stone

Etiqueta de grupo de brazo: ESWL (extracorporeal shockwaves lithotripsy)

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: 85 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Andrea Bosio, Medicine Principal Investigator Urology, University of Turin
Ubicación
Instalaciones: Urology, University of Turin
Ubicacion Paises

Italy

Fecha de verificación

May 2020

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: University of Turin, Italy

Nombre completo del investigador: Ettore Dalmasso

Título del investigador: Doctor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: RIRS (retrograde intrarenal surgery)

Tipo: Experimental

Descripción: 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.

Etiqueta: ESWL (extracorporeal shockwaves lithotripsy)

Tipo: Experimental

Descripción: 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.

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov