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In the medical world more and more procedures are performed with the use of ionizing radiation (x-ray), both diagnostic and therapeutic. The main and most known risk is the development of malignancies as a result of the use of ionizing radiation.
Purpose of this study: To examine the patient radiation dose (PRD) if the frames per second (FPS) are set differently during the five most performed endourological procedures where fluoroscopy is used (insertion/replacement of ureteral stent, (mini-)percutaneous nephrolithotomy (PCNL/PNL), ureterorenoscopy (URS) and extracorporeal shock wave lithotripsy (ESWL/SWL)) and to propose an acceptable PRD for these procedures in a multicentric study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FPS 3-5 | Experimental | Frames per second are set at 3-5 at the beginning of the procedure |
|
| FPS >5-8 | Experimental | Frames per second are set at >5-8 at the beginning of the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| frames per second | Radiation | Other settings for frames per second |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limit | Dose limit for the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in PRD | Difference in the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL when the FPS are set to 3 to 5 compared to >5 to 8 | 1 year |
| PRD different centres |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent De Coninck, MD | Contact | +32 3 650 50 56 | +32 | vincent.de.coninck@klina.be |
| Stefan De Wachter, MD | Contact | +32 3 821 33 68 | +32 | stefan.de.wachter@uza.be |
| Name | Affiliation | Role |
|---|---|---|
| Vincent De Coninck, MD | Universiteit Antwerpen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Klina | Recruiting | Brasschaat | Antwerp | 2930 | Belgium |
All data will be stored in RedCAP and will only be accessible by the principal investigator
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 6, 2023 | Apr 22, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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PRD differ between the different participating urologists and centres
| 1 year |
| PRD difference complicated cases | PRD difference between normal and complicated cases | 1 year |
| UZA | Recruiting | Edegem | Antwerp | 2650 | Belgium |
|
| D052801 | Male Urogenital Diseases |