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.
Aperçu de l'étude
Statut
Description détaillée
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).
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Stone-Free Rate
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Predictive Accuracy of the Nomogram
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- fURS Success Nomogram Validity
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .