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Predicting the Success of Flexible Ureterorenoscopy for Kidney and Upper Ureter Stones

4 de agosto de 2026 actualizado por: Abdelrahman Sayed Abdelrehim Abdelaziz, Assiut University

Validation of a Nomogram for Prediction of Success of Flexible Ureterorenoscopy for Treatment of Renal and Upper Ureteric Stones

This observational study aims to test how well a specific medical scoring tool, called a nomogram, can predict the success of a common minimally invasive surgery for kidney stones. The surgery being studied is flexible ureterorenoscopy (fURS), which is widely used to treat stones in the kidney and the upper part of the ureter. In this study, procedural success is defined as a patient being completely stone-free after their surgery.

While fURS is highly effective, the chances of completely clearing all stones can vary from person to person based on individual factors like stone size, stone volume, and anatomical characteristics. Researchers want to determine if this nomogram can accurately estimate a patient's personalized chance of achieving a stone-free outcome before the intervention takes place.

Participants in this study will be adult patients who are already scheduled to undergo fURS as part of their standard medical care. Because this is an observational study, there are no experimental treatments, participants will receive their normal surgical care.

During the study, the research team will collect standard clinical information, including:

  • Preoperative data such as age, body mass index (BMI), blood tests, and CT scan results.
  • Operative details during the surgery, such as the time it takes, the experience level of the surgeon, and the laser settings used to break up the stones.
  • Postoperative outcomes, specifically reviewing follow-up imaging to check for the presence and size of any remaining stone fragments.

By comparing the nomogram's preoperative predictions to the patients' actual surgical results, the researchers hope to validate the tool's accuracy. Confirming the reliability of this tool could help doctors better plan individualized treatments, avoid unnecessary procedures, and improve how they counsel future patients regarding their expected surgical outcomes.

Descripción general del estudio

Descripción detallada

Urolithiasis remains one of the most common urological diseases globally, characterized by increasing incidence and recurrence rates. While flexible ureterorenoscopy (fURS) has become a preferred minimally invasive treatment for renal and upper ureteric stones due to its high efficacy and low morbidity, the stone-free rate (SFR) varies significantly among patients. To optimize patient counseling and treatment selection, predictive nomograms have emerged as practical tools that integrate multiple clinical and radiological variables into a single, individualized probability estimate for achieving stone clearance.

However, external validation is a critical prerequisite before adopting any predictive model into routine clinical practice. A nomogram developed in one population may exhibit different predictive accuracy in another due to variations in patient characteristics, stone burden, and local healthcare settings. Currently, there is limited evidence regarding the performance of published fURS predictive models in Middle Eastern and Egyptian populations. This study addresses this gap by conducting an independent external validation of a published nomogram at Assiut University Hospitals.

The study involves a comprehensive, multi-phase data collection process for all enrolled participants:

  • Preoperative Assessment: Patients will undergo clinical, laboratory, and radiological evaluations. Baseline demographic data (age, sex, body mass index) and serum creatinine levels will be recorded. Stone characteristics will be evaluated using computed tomography (CT) to document stone size, volume, number, location, laterality, and the presence of hydronephrosis. CT findings specifically required to calculate the nomogram score will be systematically extracted.
  • Intraoperative Parameters: During the fURS procedure, the surgical team will prospectively record the total operative time, utilization of a ureteral access sheath, specific laser lithotripsy settings utilized for fragmentation, the operating surgeon's experience level, and any intraoperative complications encountered.
  • Postoperative Evaluation: Following the surgery, researchers will document the duration of the hospital stay, any postoperative complications, and the potential need for auxiliary procedures (such as repeat ureteroscopy, shock wave lithotripsy, or percutaneous interventions for residual stone burden).

Tipo de estudio

De observación

Inscripción (Estimado)

70

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

N/A

Método de muestreo

Muestra no probabilística

Población de estudio

The study population consists of adult patients, aged 18 years and older, of both sexes who present with renal or upper ureteric stones. These patients must be scheduled to undergo flexible ureterorenoscopy (fURS) as part of their standard clinical management. Participants will be drawn from the patient population receiving routine care at the Urology Department of Assiut University Hospitals.

Descripción

Inclusion Criteria:

  • Adult patients (≥18 years).
  • Both sexes.
  • Patients with renal stones.
  • Patients with upper ureteric stones.
  • Patients scheduled for flexible ureterorenoscopy.
  • Patients willing to provide informed consent.

Exclusion Criteria:

  • Congenital urinary tract anomalies.
  • Active urinary tract infection.
  • Pregnancy.
  • Patients with incomplete clinical or radiological data.
  • Patients lost to follow-up.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Patients Undergoing Flexible Ureterorenoscopy (fURS)
This cohort consists of adult patients (18 years and older) of both sexes diagnosed with renal or upper ureteric stones who are scheduled to undergo flexible ureterorenoscopy (fURS) as part of their routine clinical management. Preoperative characteristics, intraoperative parameters, and postoperative outcomes will be prospectively recorded to validate a predictive nomogram for determining stone-free status.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Stone-Free Rate
Periodo de tiempo: 4 weeks post-procedure
Treatment outcome determined through postoperative imaging to document the presence and size of any residual stone fragments.
4 weeks post-procedure

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Predictive Accuracy of the Nomogram
Periodo de tiempo: 4 weeks post-procedure
The discrimination ability of the nomogram to accurately predict stone-free status after the procedure, evaluated using the Area Under the Receiver Operating Characteristic (AUC-ROC) curve.
4 weeks post-procedure

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

4 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de agosto de 2026

Publicado por primera vez (Actual)

7 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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