Predicting the Success of Flexible Ureterorenoscopy for Kidney and Upper Ureter Stones
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.
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Status
Descrição detalhada
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 estudo
Inscrição (Estimado)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Stone-Free Rate
Prazo: 4 weeks post-procedure
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Treatment outcome determined through postoperative imaging to document the presence and size of any residual stone fragments.
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4 weeks post-procedure
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Predictive Accuracy of the Nomogram
Prazo: 4 weeks post-procedure
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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.
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4 weeks post-procedure
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- fURS Success Nomogram Validity
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