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

4 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

70

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Stone-Free Rate
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Predictive Accuracy of the Nomogram
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 ottobre 2027

Date di iscrizione allo studio

Primo inviato

4 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 agosto 2026

Primo Inserito (Effettivo)

7 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • fURS Success Nomogram Validity

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .