Dusting vs Basketing in RIRS: a Single-center Prospective Randomised Trial

Dusting vs Basketing in RIRS: a Single-center Prospective Randomised Trial

Patrocinadores

Patrocinador principal: Guohua Zeng

Fuente The First Affiliated Hospital of Guangzhou Medical University
Resumen breve

The investigator aims to perform a prospective and randomized controlled trial comparing the safety and efficacy of active basket extraction of fragments and stone dusting during the RIRS.

Descripción detallada

RIRS has been widely adopted and used by urologists worldwide in the management of renal stones due to less invasiveness and efficacy, especially in small to moderate-sized renal stones. RIRS has several advantages over SWL for stones less than 2 cm diameter. Most importantly, removing the stone in one session without the need for other treatment modalities.

Furthermore, the application of RIRS has expanded to larger stones reaching up to 35 mm in some cases,in spite of not being the first line therapy for the larger stones. RIRS has advantages over the PCNL especially concerning complications. Namely lower or no bleeding events and the less invasiveness of RIRS.

Options for the treatment of intrarenal stones include fragmenting the stone then extracting large fragments using a basket or dusting the stone into very small fragments then leaving the (dust) to pass spontaneously.

The idea of dusting in RIRS emerges as a counterpart of the originally taught fragmentation and basketing of the stones. Aiming to reduce multiple entries and exits for the renal system and ultimately not requiring UAS or baskets during the surgery. Thus theoretically decreasing operative time and costs with the same SFRs, In addition to minimizing the risk of ureteral injury .

So there is a debate amongst surgeons whether to laser the stone to dust or fragment and retrieve intra-renal fragments. EAU guidelines on the surgical management of urolithiasis stated that dusting strategies should be limited to the treatment of large renal stones. Without clearly differentiating between dusting or fragmentation and basketing. Cho et al; favored fragmentation technique especially for large renal stones because the dust in dusting technique may affect visualization and obscure small stone fragments. But this was an opinion and not built on a direct comparative study.

Until now, there is no consensus on how to achieve optimal stone clearance once the primary stone is fragmented with lithotripsy. And to date, no prospective randomized study has addressed the practice of active extraction vs. spontaneous passage

Estado general Unknown status
Fecha de inicio August 1, 2017
Fecha de Terminación December 2018
Fecha de finalización primaria December 2018
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Stone free rate (SFR) 4-6 weeks after surgery
Resultado secundario
Medida Periodo de tiempo
Operating time intraoperatively
Complication rates intraoperatively or 48h postoperatively
Inscripción 136
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Basketing in RIRS

Descripción: Treament of renal stones by fragmentation of stone under direct vision through a flexible ureteroscope and then actively extracting them using a basket

Etiqueta de grupo de brazo: Basketing

Tipo de intervención: Procedure

Nombre de intervención: Dusting in RIRS

Descripción: Treament of renal stones by dusting the stone under direct vision through a scope and then leaving them to pass spontaneously

Etiqueta de grupo de brazo: Dusting

Elegibilidad

Criterios:

Inclusion Criteria:

1. Patients must be a suitable operative candidate for RIRS

2. Age ≥18 years

3. Normal renal function

4. ASA score Ⅰ and Ⅱ

5. Single renal stone ≤20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm

Exclusion Criteria:

1. Pregnant subjects

2. Uncorrected coagulopathy and active urinary tract infection (UTI)

3. prior ipsilateral endourological procedure history, such as RIRS, PCNL, URS and URL

4. Patients who underwent transplant or urinary diversion.

5. Congenital abnormalities.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Guohua Zeng, PH.D & MD Principal Investigator The First Affiliated Hospital of Guangzhou Medical University
Contacto general

Apellido: Guohua Zeng, Ph.D and M.D.

Teléfono: +86 13802916676

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Investigador: Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University Guohua Zeng, Ph.D & MD. +86 13802916676 [email protected] Guohua Zeng, Ph.D & MD. Principal Investigator Chao Cai, PH.D & MD Sub-Investigator
Ubicacion Paises

China

Fecha de verificación

August 2018

Fiesta responsable

Tipo: Sponsor-Investigator

Afiliación del investigador: The First Affiliated Hospital of Guangzhou Medical University

Nombre completo del investigador: Guohua Zeng

Título del investigador: Vice president

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

Etiqueta: Dusting

Tipo: Experimental

Descripción: small stones will be left to pass spontaneously.

Etiqueta: Basketing

Tipo: Experimental

Descripción: stones will be actively extracted.

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov