Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
NCT07155005
Calculi, Female Urogenital Diseases
View Trial DetailsNCT Number: NCT07753096
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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:
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 4 weeks post-procedure
Treatment outcome determined through postoperative imaging to document the presence and size of any residual stone fragments.
Time frame: 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.
Assiut University
Other
Validation of a Nomogram for Prediction of Success of Flexible Ureterorenoscopy for Treatment of Renal and Upper Ureteric Stones
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