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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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).
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
|---|
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Stone-Free Rate
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Predictive Accuracy of the Nomogram
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- fURS Success Nomogram Validity
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .