PRedictive Accuracy of Initial Stone Burden Evaluation.

Study Overview
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Brief Summary
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This study is intended to be a prospective registry of patients undergoing any kind of stone treatment that have a pre-operative CT available. This imaging will be used to measure the stone burden in three different ways: in a single dimension (cumulative stone diameter), in two dimensions (surface area) and in three dimensions (volume).The primary purpose is to identify what way of measuring stone burden is most predictive of outcomes after stone treatment such as stone free status, operative time and complications.

Detailed Description
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The current EAU and AUA guidelines still base the recommendations for stone treatment on cumulative stone diameter, a linear measurement of the stone burden. Multiple nomograms rather use the stone burden's surface area to predict post-operative outcomes. More recently, volume has been prposed as the most accurate measure of stone burden and the variable to be reported in stone treatment literature. Although inuitively a three dimensional evaluation is most likely the most accurate representation of the stone burden to be treated. Several reports however have compared different ways of measuring stone burden and could not confidently identify volume as the most accurate predictor of surgical outcomes. With this study, we aim to prospectively collect data on a large group of patients that have a pre-operative CT scan available. This imaging will be used to assess the stone burden in different ways, linear, two dimensional and three dimensional. Both procedural and post-operative data will be collected to identify which of the measurements is most accurate in predicting outcomes such as stone free status, operative time and complications such as bleeding. Patients can be included regardless of the procedure that is proposed to treat the stone. After inclusion and after having undergone the procedure, at least one post-operative assessment is necessary to be able to evaluate the pre-operative variables against post-operative outcomes.

Official Title
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Comparison of Predictive Value of Different Stone Burden Measurements for Outcomes After Urinary Stone Treatment.

Conditions
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Urolithiasis, Ureterolithiasis, Nephrolithiasis

Intervention / Treatment
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* Diagnostic Test: Computed Tomography, CSD
* Diagnostic Test: Computed Tomography, SA
* Diagnostic Test: Computed Tomography, 3D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Availability of computed tomography imaging Undergoing any of the previously described procedures: extracorporeal shockwave lithotripsy, uretero(reno)scopy or percutaneous nephrolithotomy Able to read and understand the information regarding the study and able to provide informed consent Exclusion Criteria: Under the stated age limit No pre-operative computed tomography imaging available

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| extracorporeal shockwave lithotripsy<br>Patients that are included in the study and undergo a shockwave lithotripsy. The pre- and postoperative assessment remains the same across groups | Diagnostic Test: Computed Tomography, CSD<br>* Measurement of the stone burden by cumulative stone diameter, the sum of linear longest diameters of all the stones to be treated within one patient as measured on the CT or by additional rendering software<br>* Other names: Cumulative Stone Diameter;Diagnostic Test: Computed Tomography, SA<br>* Measurement of the stone burden by surface area, the sum of surface areas of all the stones to be treated within one patient as measured on the CT or by additional rendering software<br>* Other names: Stone Surface Area;Diagnostic Test: Computed Tomography, 3D<br>* Measurement of the stone burden by volume of all the stones to be treated within one patient, as measured on the CT or by additional rendering software<br>* Other names: Stone Volume;|
| uretero(reno)scopy<br>Patients that are included in the study and undergo a semirigid or flexible uretero(reno)scopy. The pre- and postoperative assessment remains the same across groups | Diagnostic Test: Computed Tomography, CSD<br>* Measurement of the stone burden by cumulative stone diameter, the sum of linear longest diameters of all the stones to be treated within one patient as measured on the CT or by additional rendering software<br>* Other names: Cumulative Stone Diameter;Diagnostic Test: Computed Tomography, SA<br>* Measurement of the stone burden by surface area, the sum of surface areas of all the stones to be treated within one patient as measured on the CT or by additional rendering software<br>* Other names: Stone Surface Area;Diagnostic Test: Computed Tomography, 3D<br>* Measurement of the stone burden by volume of all the stones to be treated within one patient, as measured on the CT or by additional rendering software<br>* Other names: Stone Volume;|
| percutaneous nephrolithotomy<br>Patients that are included in the study and undergo a percutaneous nephrolithotomy. The pre- and postoperative assessment remains the same across groups | Diagnostic Test: Computed Tomography, CSD<br>* Measurement of the stone burden by cumulative stone diameter, the sum of linear longest diameters of all the stones to be treated within one patient as measured on the CT or by additional rendering software<br>* Other names: Cumulative Stone Diameter;Diagnostic Test: Computed Tomography, SA<br>* Measurement of the stone burden by surface area, the sum of surface areas of all the stones to be treated within one patient as measured on the CT or by additional rendering software<br>* Other names: Stone Surface Area;Diagnostic Test: Computed Tomography, 3D<br>* Measurement of the stone burden by volume of all the stones to be treated within one patient, as measured on the CT or by additional rendering software<br>* Other names: Stone Volume;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone Free Status | Any residual stone fragments after the initial treatment | 1 day to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | Time needed to treat the stone burden as measured during one treatment session | intra-operative | 
| Complication | Any complication thet can be attributed to the procedure that was performed | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ureteroscopy, extracorporeal shockwave lithotripsy, percutaneous nephrolithotomy, stone burden, non-contrast computed tomography