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The goal of this clinical trial is to learn whether an exoskeleton-supported radiation protection system can reduce radiation exposure and musculoskeletal strain in vascular surgeons during endovascular aortic repair procedures, compared with standard lead aprons. Researchers will compare procedures performed with exoskeleton-supported protection and procedures performed with standard lead aprons. Radiation exposure, physical strain, fatigue, and discomfort will be assessed during and after procedures.
This is a prospective, randomized, controlled crossover study evaluating an exoskeleton-supported radiation protection system versus standard lead aprons during complex endovascular aortic repair procedures. The study will be conducted at the Department of Vascular Surgery, University Clinical Hospital No. 2 in Szczecin, Pomeranian Medical University.
Two vascular surgeons will participate in the study and perform a total of 60 procedures, including EVAR, IBD-EVAR, and BEVAR. Before each procedure, the type of radiation protection will be randomly assigned: a standard lead apron or an exoskeleton-supported protective system with visor. Each procedure will be performed in full with the assigned protection system, without switching during the intervention.
Operator radiation exposure will be measured in real time using 3 personal dosimeters per operator. Musculoskeletal load will be assessed using shoulder load sensors. After each procedure, operators will complete standardized questionnaires evaluating fatigue and discomfort, including the Borg CR-10 scale, visual analog scale, and Nordic Questionnaire.
The primary objective is to determine whether the exoskeleton-supported protection system reduces operator radiation exposure and musculoskeletal strain during endovascular aortic repair procedures. The results may help improve occupational safety during complex fluoroscopy-guided vascular interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exoskeleton-Supported Protection System | Experimental | Endovascular aortic repair procedures performed with an exoskeleton-supported radiation protection system with visor. |
|
| Standard Lead Apron | Active Comparator | Endovascular aortic repair procedures performed with standard lead apron radiation protection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exoskeleton-supported radiation protection system | Device | An exoskeleton-supported radiation protection system with visor used by the operator during endovascular aortic repair procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Operator musculoskeletal strain assessed during endovascular aortic repair procedures using shoulder load sensors. | Operator weight distribution and physical load assessed during endovascular aortic repair procedures using foot-mounted load sensors. | During each procedure |
| Operator radiation exposure | Operator radiation exposure measured during endovascular aortic repair procedures using real-time personal dosimetry. | During each procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paweł Rynio, MD, PhD | Contact | 914661156 | p.rynio@spsk2.szczecin.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Hospital No. 2, Pomeranian Medical University | Recruiting | Szczecin | West Pomeranian Voivodeship | 70-111 | Poland |
Individual participant data will not be shared because of the small sample size and the risk of participant identification.
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| Standard lead apron | Device | A standard lead apron used by the operator during endovascular aortic repair procedures. |
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