Augmented Reality, Bypass Surgery, Chronic Cerebral Ischemia, Extended Reality (XR), Moyamoya Disease
Conditions
Brief summary
This study will evaluate the application of a metaverse-based surgical simulation platform in extracranial-intracranial (EC-IC) bypass surgery. The study population will include patients with moyamoya disease or chronic cerebral ischemia who are scheduled to undergo EC-IC bypass surgery. Before surgery, preoperative brain computed tomography images will be imported into the metaverse surgical simulation platform. During surgery, extended reality technology will be used to provide precise localization of the relevant vessels, including both the donor and recipient arteries. The primary objective is to assess the localization accuracy of this platform. The study will also investigate whether this technology can facilitate a minimally invasive surgical approach and improve surgical safety.
Interventions
DEVICENTU OpVerse surgical simulation platform
NTU OpVerse is a patient-specific metaverse-based surgical simulation and assistance platform developed through collaboration among National Taiwan University Hospital, National Taiwan University, and technology partners. The platform integrates medical-image processing, three-dimensional reconstruction, digital-twin technology, and extended reality, including virtual, augmented, and mixed-reality applications. Patient-specific computed tomography or magnetic resonance imaging data can be imported into the platform and reconstructed into interactive three-dimensional anatomical models. These models allow surgeons to visualize the spatial relationships among target lesions, blood vessels, organs, bones, and other relevant anatomical structures. Through an immersive extended-reality interface, surgeons can manipulate the reconstructed models, examine them from different perspectives, and conduct individualized preoperative planning and procedural simulation.
Sponsors
National Taiwan University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients diagnosed with ischemic moyamoya disease, moyamoya syndrome, or chronic intracranial internal carotid artery stenosis or occlusion (chronic ICA stenosis/occlusion). * Patients scheduled to undergo extracranial-intracranial bypass surgery (EC-IC bypass), including superficial temporal artery-middle cerebral artery bypass (STA-MCA bypass), superficial temporal artery trunk-interposition graft-middle cerebral artery bypass (STA trunk-graft-MCA bypass), or other cerebral revascularization procedures using the superficial temporal artery or another branch of the external carotid artery system (STA/ECA system) as the donor blood supply.
Exclusion criteria
* Presence of a contraindication to computed tomography (CT) scanning. * Presence of a severe systemic illness that would prevent participation in subsequent study assessments, such as poorly controlled diabetes mellitus, active malignancy, or severe cardiac disease. * The need for emergency surgery without sufficient time to complete image-based modeling and registration. * Presence of scalp lesions, wounds, or anatomical deformities that prevent reliable surface registration. * The XR registration result is considered unreliable by the research team and may potentially compromise surgical safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of XR-Assisted Superficial Temporal Artery Localization | During preoperative surgical planning and intraoperative confirmation on the day of surgery. | Accuracy will be assessed as the absolute distance, measured in millimeters, between the superficial temporal artery location marked using the XR-assisted surgical planning system and the actual superficial temporal artery location identified by vascular ultrasonography. The mean absolute distance error across participants will be reported. |
| Accuracy of XR-Assisted Middle Cerebral Artery Recipient-Vessel Prediction | From preoperative surgical planning to intraoperative selection of the recipient vessel on the day of surgery. | Accuracy will be assessed as the absolute distance, measured in millimeters, between the anastomosis site predicted using the XR-assisted surgical planning system and the actual recipient-vessel anastomosis site selected intraoperatively. The mean absolute distance error across participants will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| XR-Assisted STA Localization Time | During preoperative preparation on the day of surgery. | The time required to localize and mark the superficial temporal artery and middle cerebral artery using the XR-assisted system will be measured in minutes, from initiation of XR registration and localization to completion of skin marking. |
| Time From Skin Incision to Identification of the Recipient Vessel | During the surgical procedure on the day of surgery. | The time from the initial skin incision to intraoperative identification of the middle cerebral artery recipient vessel selected for bypass will be measured in minutes. |
| Total Operative Time | During the surgical procedure on the day of surgery. | Total operative time will be measured in minutes, from the initial skin incision to completion of skin closure. |
| Skin-Incision Length | At completion of skin closure on the day of surgery. | The length of the final skin incision will be measured in centimeters after completion of the surgical procedure. |
| Maximum Craniotomy Diameter | During the surgical procedure on the day of surgery. | The maximum diameter of the completed craniotomy will be measured in centimeters intraoperatively. |
| Intraoperative Enlargement of the Planned Craniotomy | During the surgical procedure on the day of surgery. | The number and percentage of participants requiring intraoperative enlargement of the craniotomy beyond the preoperatively planned dimensions will be reported. |
| Intraoperative Bypass Blood Flow | Immediately after completion of the bypass anastomosis on the day of surgery. | Blood flow through the completed bypass will be measured in milliliters per minute using an intraoperative flow-measurement device after completion of the anastomosis. |
| Postoperative Ischemic Complications | From completion of surgery through 30 days after surgery. | The number and percentage of participants experiencing a new postoperative cerebral ischemic event, including transient ischemic attack or ischemic stroke, will be reported. Events will be determined by neurological assessment and clinically indicated neuroimaging. |
| Postoperative Hemorrhagic Complications | From completion of surgery through 30 days after surgery. | The number and percentage of participants experiencing a new postoperative intracranial hemorrhagic complication will be reported. Events will be determined by neurological assessment and postoperative neuroimaging |
| Change in Modified Rankin Scale Score | From baseline before surgery to 30 days after surgery. | The change in modified Rankin Scale score will be calculated as the postoperative score minus the preoperative baseline score. The modified Rankin Scale ranges from 0 to 6, with higher scores indicating greater disability. |
| Length of Intensive Care Unit Stay | From completion of surgery through discharge from the intensive care unit, up to 30 days after surgery. | The duration of postoperative intensive care unit stay will be measured in days, from admission to the intensive care unit after surgery to transfer out of the intensive care unit. |
| Total Length of Hospital Stay | From the date of surgery through hospital discharge, up to 30 days after surgery. | The total postoperative hospital stay will be measured in days, from the date of surgery to the date of hospital discharge. |
Countries
Taiwan
Contacts
CONTACTChiu Hao Hsu
Outcome results
None listed