Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones

TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery

Patrocinadores

Patrocinador principal: University of Zurich

Fuente University of Zurich
Resumen breve

The purpose of this study is to compare two established modalities for the treatment of kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with stone-extraction). Comparison of the stone-free rates 3month postoperative.

- Trial with surgical intervention

Estado general Unknown status
Fecha de inicio October 2011
Fecha de Terminación February 2014
Fecha de finalización primaria February 2014
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
stonefree-rates 3month after therapy 3 month
Inscripción 230
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Extracorporal shockwave lithotripsy

Descripción: Extracorporal shockwave lithotripsy

Etiqueta de grupo de brazo: Extracorporal shockwave lithotripsy

Tipo de intervención: Procedure

Nombre de intervención: Retrograde intrarenal surgery

Descripción: Retrograde intrarenal surgery

Etiqueta de grupo de brazo: Retrograde intrarenal surgery

Elegibilidad

Criterios:

Inclusion criteria: - kidneystones requiring treatment up to an maximal size of 15mm (singular or multiple kidneystones with at least one stone with min. 5mm of size)

- male and female patients between 18 and 99 years

- informed consent signed by patient after explanation of the both treatment-modalities

Exclusion criteria: - age < 18 or > 99

- pregnancy

- breastfeeding mother

- disorders of blood clotting

- kidneystones > 15mm

- aneurysms of the aorta or renal artery

- severe skeletal deformations which hamper one of the treatment modalities

- synchronous stones of the ipsilateral ureter

- stones which can not visualized which X-ray or sonography

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Contacto general

Apellido: Damian Weber, MD

Teléfono: +41 44 2555407

Email: [email protected]

Ubicación
Instalaciones: Estado: University Hospital Zurich, Urology
Ubicacion Paises

Switzerland

Fecha de verificación

January 2012

Fiesta responsable

Tipo: Sponsor

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

Etiqueta: Extracorporal shockwave lithotripsy

Tipo: Active Comparator

Etiqueta: Retrograde intrarenal surgery

Tipo: Active Comparator

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov