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Enrolling by Invitation

NCT Number: NCT04746378

PRedictive Accuracy of Initial Stone Burden Evaluation.

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ghent

Ghent, Eastern-Flanders, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography, CSD

Diagnostic Test

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 names: Cumulative Stone Diameter

Computed Tomography, SA

Diagnostic Test

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 names: Stone Surface Area

Computed Tomography, 3D

Diagnostic Test

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 names: Stone Volume

Primary outcomes

  1. Stone Free Status

    Time frame: 1 day to 3 months

    Any residual stone fragments after the initial treatment

Secondary outcomes

  1. Operative Time

    Time frame: intra-operative

    Time needed to treat the stone burden as measured during one treatment session

  2. Complication

    Time frame: 30 days

    Any complication thet can be attributed to the procedure that was performed

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PRAISE

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Feb 9, 2021
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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