- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07601932
Patient Positioning for Treatment of Proximal Ureteral Stones
Optimal Patient Positioning and Strategy for the Treatment of Proximal Ureteral Stones
Ureteroscopic management of proximal ureteral stones presents technical challenges including stone retropulsion, prolonged operative time, and conversion to intrarenal treatment. Reverse Trendelenburg positioning has been shown to reduce proximal stone migration and operative time in ureteral stones, while the T-tilt position improves intrarenal stone clearance. The optimal strategy for proximal ureteral stones (treating stones in situ using reverse Trendelenburg versus pushing stones into the kidney followed by intrarenal treatment in T-tilt) remains unknown.
This randomized controlled trial compares these two strategies, with primary focus on operative time as a measure of procedural efficiency.
A total of 54 patients (27 per arm) will be enrolled at Mount Sinai West.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Ureteroscopy has become a primary modality for the management of ureteral and renal calculi due to its high efficacy, minimally invasive nature, and favorable safety profile. Despite advances in flexible ureteroscopy, laser lithotripsy, and access technologies, proximal ureteral stones remain technically challenging, largely due to their tendency to migrate retrograde into the kidney, leading to prolonged operative time, increased need for flexible ureteroscopy, and lower procedural efficiency.
Stone retropulsion is influenced by laser energy, irrigation flow, ureteral anatomy, and gravitational forces. Several mechanical and laser-based strategies have been explored to mitigate migration, though results have been variable. Patient positioning represents a simple and cost-neutral intervention that may alter stone behavior intraoperatively without requiring additional devices.
Reverse Trendelenburg positioning has recently been shown to reduce proximal stone migration and improve operative efficiency during ureteroscopic treatment of ureteral stones. In a randomized controlled trial, patients positioned in reverse Trendelenburg experienced lower rates of retropulsion, reduced need for conversion to flexible ureteroscopy, and shorter operative times compared with standard positioning. However, this study included stones across multiple ureteral segments and did not focus specifically on proximal ureteral stones, which may have distinct anatomical and migration characteristics.
Conversely, T-tilt positioning has been investigated in the context of intrarenal stone treatment. Prior randomized evidence demonstrated that T-tilt positioning during retrograde intrarenal surgery resulted in higher stone-free rates, likely due to improved gravitational alignment of calyces and enhanced fragment clearance. These findings suggest that positioning may also optimize intrarenal lithotripsy efficiency once stones migrate into the kidney.
For proximal ureteral stones, two competing operative strategies are commonly used in clinical practice: (1) in situ ureteral treatment with efforts to prevent migration, potentially optimized by reverse Trendelenburg positioning, or (2) intentional pushback of the stone into the kidney followed by intrarenal lithotripsy under positioning conditions favorable for fragment clearance, such as T-tilt.
The decision to use one strategy over another is based on surgeon preference. Currently, there are no guidelines or standards favoring either approach. To date, no randomized study has directly compared these two positioning-based strategies for proximal ureteral stones. Given that operative time is strongly associated with anesthesia exposure, procedural cost, complication risk, and resource utilization, it represents a clinically meaningful and objective primary endpoint to evaluate procedural efficiency between approaches.
This study seeks to address an important gap in endourologic practice by determining the optimal positioning strategy for proximal ureteral stone management, with the goal of improving operative efficiency, reducing procedural burden, and informing evidence-based surgical decision-making.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mantu Gupta, MD
- Número de teléfono: 212-241-1272
- Correo electrónico: mantu.gupta@mountsinai.org
Copia de seguridad de contactos de estudio
- Nombre: Blair Gallante, MPH
- Número de teléfono: 212-241-1272
- Correo electrónico: blair.gallante@mountsinai.org
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10019
- Reclutamiento
- Mount Sinai West
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Investigador principal:
- Mantu Gupta, MD
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Contacto:
- Mantu Gupta, MD
- Número de teléfono: 212-241-1272
- Correo electrónico: mantu.gupta@mountsinai.org
-
Contacto:
- Blair Gallante, MPH
- Número de teléfono: 212-241-1272
- Correo electrónico: blair.gallante@mountsinai.org
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion criteria:
- Adults aged 18 years and older.
- Diagnosed with kidney stones and scheduled for fURS.
- Stone burden > 1 cm and/or multiple stones will be eligible.
- Able and willing to provide informed consent.
Exclusion criteria:
- Pregnant persons as determined by pre-operative urine pregnancy test (standard of care at the institution)
- Untreated UTI
- Patients with urinary anomalies (e.g., urinary diversion, ureteral reconstruction, horseshoe kidney)
- Single stone < 1 cm
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Reverse Trendelenburg Position
Participants undergo ureteroscopic lithotripsy in reverse Trendelenburg positioning with attempted in situ treatment of the proximal ureteral stone to minimize proximal migration.
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Patients will be positioned in reverse Trendelenburg at a 20 degree incline with the use of a digital protractor.
Lithotripsy will be performed within the ureter with attempts to prevent proximal migration and until all fragments are removed.
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Comparador activo: T-Tilt Position
Participants undergo intentional relocation of the proximal ureteral stone into the kidney followed by intrarenal lithotripsy performed in the T-tilt position.
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Stone will be intentionally relocated into the kidney when feasible, followed by intrarenal lithotripsy in T-tilt position.
In the T-tilt position the table is angled 15-degree Trendelenburg and 15-degree airplane away from the surgical side kidney with the use of a digital protractor.
This allows fragments to rest in a superior and medial position away from the lower pole to facilitate removal.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total operative time
Periodo de tiempo: Immediately postoperatively on the day of surgery
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Operative time will be used to compare procedural efficiency
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Immediately postoperatively on the day of surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of participants stone-free
Periodo de tiempo: From Week 4 to Week 6 postoperatively
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Proportion of participants without residual stone fragments on postoperative CT imaging
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From Week 4 to Week 6 postoperatively
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Proportion of procedures requiring additional equipment or procedural maneuvers
Periodo de tiempo: Immediately after completion of surgery on the day of procedure
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Proportion of procedures requiring additional equipment or procedural maneuvers beyond the initially planned operative strategy to complete stone treatment
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Immediately after completion of surgery on the day of procedure
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Proportion of strategy failure
Periodo de tiempo: Assessed immediately at completion of surgery on the day of procedure
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Proportion of cases in which the randomized operative strategy could not be successfully executed intraoperatively
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Assessed immediately at completion of surgery on the day of procedure
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Incidence of Complications
Periodo de tiempo: Through postoperative day 30
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Incidence of postoperative complications, defined as any Clavien-Dindo complications, emergency department visits, or readmission related to the procedure.
Outcome is recorded as the occurrence of a complication event (yes or no).
Each participant is counted once, and the outcome is recorded as a binary variable indicating whether any of these events occurred or did not occur.
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Through postoperative day 30
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mantu Gupta, MD, Icahn School of Medicine at Mount Sinai
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY-26-00168
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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