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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years).

Both sexes.

Patients with renal stones.

Patients with upper ureteric stones.

Disqualifiers

Congenital urinary tract anomalies.

Active urinary tract infection.

Pregnancy.

Patients with incomplete clinical or radiological data.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 1 trial group
Group A: Patients Undergoing Flexible Ureterorenoscopy (fURS)

Trial outcomes

Primary outcomes

1

Stone-Free Rate

Treatment outcome determined through postoperative imaging to document the presence and size of any residual stone fragments.

Time frame
4 weeks post-procedure

Secondary outcomes

1

Predictive Accuracy of the Nomogram

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.

Time frame
4 weeks post-procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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