Personalized Treatment Planning in Intracranial Aneurysm Surgeries.

Study Overview
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Brief Summary
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Patients who will undergo a intracranial aneurysm (IA) surgery are educated concerning their disease and the surgical procedure.The objective of this study is to explore the advantages of conventional, virtual reality and 3D stereolithographic models for patient and resident education in the treatment of lAs.

Detailed Description
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Patient understanding of their medical condition and treatment satisfaction has gained increasing attention in medicine. As for neurosurgical conditions however, the treatment plan is often difficult for patients to comprehend, with many of them having an inaccurate understanding of the involved anatomy. Novel technologies therefore may play a role in facilitating patient education. In particular, conventional 2D images makes it sometimes difficult for surgeons to inform their patients about the planned intervention and potential complications. This is why new modalities have been developed for patient information and may have further an impact on resident education to better estimate the treatment plan and potential complication. For the latter, given that intracranial aneurysms (lAs) are increasingly treated via endovascular methods, training opportunities are reduced and understanding of the vascular anatomy can become difficult. The objective of this study is to explore the advantages of conventional, virtual reality and 3D stereolithographic models for patient and resident education in the treatment of lAs.

Official Title
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Personalized 3D Virtual and Printed Model Versus Conventional Images for the Education of the Treatment Planning in Intracranial Aneurysm Surgeries.

Conditions
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Aneurysm Cerebral

Intervention / Treatment
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* Procedure: Questionnaire and use of 3 D tools


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing elective surgery for non-ruptured IA during the study period will be considered for inclusion. Patients are included if they are at least 18 years old and are able to give informed consent and signed the informed consent form. Exclusion Criteria: Patients with ruptured or mycotic IA are not considered. Furthermore, patients elected for IA surgery that are younger than 18 years old, as well as patients who are unable to give informed consent (e.g. neurological impairments) will not be included.

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

| Intervention/Treatment |
| --- |
|Procedure: Questionnaire and use of 3 D tools|Resulting computer tomography(CT) results are transferred to a 3 D projection. Patients will be asked to wear 3 D glasses to be able visualizing the diagnosed vascular pathology. The physician will explain the disaese and treatment. The patient is ask to fill out a questionnaire post 3D consulting|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of the planned intervention and clip placement. | Assessment of the 3D models regarding the accuracy of the planned intervention. In specific the following surgical steps are evaluated and assessed during aneurysm clipping and compared to the ideal preoperative forecast based on the 3D model (GRF_clip anticipation): Temporary clips: (1) number of temporary clips; (2) left- or right-handed application; (3) position on parent artery; (4) length of the clip; (5) shape of the clip. Permanent clips: (6) number of permanent clips; (7) left- or right-handed application; (8) length of the clip; (9) shape of the clip. | 6 months post interventional | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient education | Assessment of ischemia (large and perforating artery compromise), time of temporary clip occlusion, morbidity, clinical outcome., To investigate the impact of personalized 3D printed model on patient information before surgery, study participants will be presented with their individual 3D printed model and a questionaire to analze an improvement in their understanding of basic anatomy, the planned surgical procedure, and understanding the complications related to the surgery will be assessed (GRF_patient satisfaction). To further determine if 3D printed models can be used to improve intraoperative pattern recognition and be a valuable adjunct in neurosurgical resident education, a comparison of conventional imaging with CT-scan, 3D-RA, 3D model will be assessed (GRF_resident education). | 6 months post interventional |