Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery
The Impact of Two Different Ureteral Access Sheaths on Success and Complications in Endoscopic Kidney Stone Surgery
This prospective, randomized, comparative study aims to evaluate the impact of aspirating and non-aspirating ureteral access sheaths on success rates and complications in patients undergoing retrograde intrarenal surgery (RIRS) for kidney stones. A total of 70 patients with renal stones smaller than 2 cm will be enrolled and randomly assigned to two groups. One group will undergo RIRS using a non-aspirating ureteral access sheath, while the other group will be treated using an aspirating ureteral access sheath.
The primary outcome of the study is the stone-free rate, which will be assessed at postoperative follow-up. Secondary outcomes include operative time, fluoroscopy time, length of hospital stay, postoperative complications according to the Clavien-Dindo classification, infection-related parameters, and the need for ureteral stenting.
The study aims to determine whether the use of an aspirating access sheath improves surgical outcomes by reducing intrarenal pressure, enhancing visualization, and decreasing complication rates. The findings are expected to contribute to optimizing device selection and improving clinical outcomes in endoscopic kidney stone surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is designed as a prospective, randomized, comparative clinical trial to evaluate the effectiveness and safety of aspirating versus non-aspirating ureteral access sheaths in patients undergoing retrograde intrarenal surgery (RIRS) for kidney stones.
Ureteral access sheaths are commonly used during RIRS to facilitate repeated access to the collecting system, maintain low intrarenal pressure, and improve visualization. While conventional non-aspirating sheaths allow passive outflow of irrigation fluid, aspirating sheaths provide active suction, which may enhance fragment evacuation, reduce intrarenal pressure, and potentially decrease infectious complications. However, comparative clinical data between these two approaches remain limited.
In this study, a total of 70 patients aged 18 to 75 years with renal stones smaller than 2 cm will be enrolled after providing informed consent. Patients will be randomized into two groups using a computer-generated block randomization method. The first group will undergo RIRS using a non-aspirating ureteral access sheath, while the second group will undergo RIRS using an aspirating ureteral access sheath. All procedures will be performed using a standardized surgical technique.
Demographic characteristics, stone-related parameters, and perioperative variables will be recorded. Postoperative follow-up will include clinical and radiological evaluation. Stone-free status will be assessed during postoperative follow-up. Complications will be classified according to the Clavien-Dindo classification. Additional parameters, including operative time, fluoroscopy time, length of hospital stay, infection-related laboratory findings, and the need for auxiliary procedures, will also be evaluated.
The aim of this study is to determine whether the use of an aspirating ureteral access sheath improves surgical efficiency and safety compared with a conventional sheath. The results are expected to provide evidence to guide clinical decision-making in endoscopic kidney stone surgery.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: AHMET TAŞCI
- Número de teléfono: +905531596690
- Correo electrónico: ahmettasci400@gmail.com
Ubicaciones de estudio
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Çorum
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Çorum, Çorum, Turquía (Türkiye), 19040
- Reclutamiento
- Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
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Contacto:
- AHMET TAŞCI
- Número de teléfono: +90 553 159 6690
- Correo electrónico: ahmettasci400@gmail.com
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Investigador principal:
- AHMET TAŞCI
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Sub-Investigador:
- MUSA EKİCİ
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients aged between 18 and 75 years
- Patients diagnosed with kidney stones smaller than 2 cm
- Patients scheduled for retrograde intrarenal surgery (RIRS)
- Patients who provide written informed consent
Exclusion Criteria:
- Patients with active urinary tract infection
- Patients with coagulopathy
- Pregnant patients
- Patients unable to tolerate the lithotomy position
- Patients with incomplete clinical or laboratory data
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Non-aspirating ureteral access sheath
Patients undergoing retrograde intrarenal surgery (RIRS) using a non-aspirating ureteral access sheath.
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A conventional ureteral access sheath that allows passive outflow of irrigation fluid during RIRS.
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Experimental: Aspirating ureteral access sheath
Patients undergoing retrograde intrarenal surgery (RIRS) using an aspirating ureteral access sheath.
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A ureteral access sheath with an active suction system that facilitates removal of irrigation fluid and stone fragments during RIRS.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Stone-free status
Periodo de tiempo: At 3 weeks postoperatively
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Stone-free status is defined as the absence of residual stones on low-dose non-contrast computed tomography or plain urinary system radiography at 3 weeks postoperatively.
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At 3 weeks postoperatively
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Operation time
Periodo de tiempo: Measured during surgery, from incision to closure (intraoperative period)
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Operative time is defined as the duration from the start of the operation to its completion.
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Measured during surgery, from incision to closure (intraoperative period)
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Length of hospital stay
Periodo de tiempo: From postoperative admission to hospital discharge, assessed up to 30 days
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Length of hospital stay is defined as the time from postoperative hospital admission to hospital discharge, measured in days.
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From postoperative admission to hospital discharge, assessed up to 30 days
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Intraoperative complications
Periodo de tiempo: From start to completion of surgery (intraoperative period)
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Intraoperative complications are defined as any adverse events occurring during the surgical procedure, including but not limited to bleeding, ureteral injury, or technical difficulties.
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From start to completion of surgery (intraoperative period)
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Postoperative infectious complications
Periodo de tiempo: From end of surgery to 7 days postoperatively
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Postoperative infectious complications are defined as infection-related adverse events occurring after surgery, including fever, urinary tract infection, and sepsis.
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From end of surgery to 7 days postoperatively
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Gauhar V, Traxer O, Castellani D, Sietz C, Chew BH, Fong KY, Hamri SB, Gokce MI, Gadzhiev N, Galosi AB, Yuen SKK, El Hajj A, Ko R, Zawadzki M, Sridharan V, Lakmichi MA, Corrales M, Malkhasyan V, Ragoori D, Soebhali B, Tan K, Chai CA, Tursunkulov AN, Tanidir Y, Persaud S, Elshazly M, Kamal W, Tefik T, Shrestha A, Tiong HC, Somani BK. Could Use of a Flexible and Navigable Suction Ureteral Access Sheath Be a Potential Game-changer in Retrograde Intrarenal Surgery? Outcomes at 30 Days from a Large, Prospective, Multicenter, Real-world Study by the European Association of Urology Urolithiasis Section. Eur Urol Focus. 2024 Dec;10(6):975-982. doi: 10.1016/j.euf.2024.05.010. Epub 2024 May 24.
- Kwok JL, Somani B, Sarica K, Yuen SKK, Zawadzki M, Castellani D, Persaud S, Chai CA, Kamal W, Tefik T, Tursunkulov AN, Soebhali B, Hajj AE, Ko R, Fong KY, Dragos L, Tanidir Y, Angerri O, Traxer O, Gauhar V. Multicenter outcome analysis of different sheath sizes for Flexible and Navigable Suction ureteral access sheath (FANS) ureteroscopy: an EAU Endourology collaboration with the global FANS study group. Urolithiasis. 2024 Nov 15;52(1):162. doi: 10.1007/s00240-024-01662-4.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales masculinas
- Cálculos
- Condiciones Patológicas, Anatómicas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Urolitiasis
- Cálculos urinarios
- Nefrolitiasis
- Condiciones Patológicas, Signos y Síntomas
- Cálculos renales
Otros números de identificación del estudio
- ETIK-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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