PRedictive Accuracy of Initial Stone Burden Evaluation.

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

Sponsors

Lead Sponsor: University Hospital, Ghent

Collaborator: EAU Young Academic Urologists Urolithiasis and Endourology Working Group
European Association of Urology Section of Uro-Technology
Endourological Society TOWER Research Team

Source University Hospital, Ghent
Brief Summary

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

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.

Overall Status Not yet recruiting
Start Date 2021-08-08
Completion Date 2023-12-31
Primary Completion Date 2023-01-01
Study Type Observational
Primary Outcome
Measure Time Frame
Stone Free Status 1 day to 3 months
Secondary Outcome
Measure Time Frame
Operative Time intra-operative
Complication 30 days
Enrollment 1000
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Computed Tomography, CSD

Description: 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

Other Name: Cumulative Stone Diameter

Intervention Type: Diagnostic Test

Intervention Name: Computed Tomography, SA

Description: 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

Other Name: Stone Surface Area

Intervention Type: Diagnostic Test

Intervention Name: Computed Tomography, 3D

Description: 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

Other Name: Stone Volume

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Thomas Tailly, MD Principal Investigator University Hospital, Ghent
Overall Contact

Last Name: Thomas Tailly, MD

Phone: +3293322276

Email: [email protected]

Location
Facility: Contact: University Hospital Ghent Thomas Tailly, MD +3293322276 [email protected]
Location Countries

Belgium

Verification Date

2021-07-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: extracorporeal shockwave lithotripsy

Description: Patients that are included in the study and undergo a shockwave lithotripsy. The pre- and postoperative assessment remains the same across groups

Label: uretero(reno)scopy

Description: 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

Label: percutaneous nephrolithotomy

Description: Patients that are included in the study and undergo a percutaneous nephrolithotomy. The pre- and postoperative assessment remains the same across groups

Acronym PRAISE
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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