The "STARS" study: advanced preoperative rehearsal and intraoperative navigation in neurosurgical oncology.

BACKGROUND: Neurosurgical 3D visualizers and simulators are innovative devices capable of defining a surgical strategy in advance and possibly making neurosurgery safer by rehearsing the phases of the operation beforehand. The aim of this study is to evaluate Surgical Theater™ (Surgical Theater LLC, Mayfield, OH, USA), a new 3D neurosurgical planning, simulation, and navigation system, and qualitatively assess its use in the operating room. METHODS: Clinical data were collected from 30 patients harboring various types of brain tumors; Surgical Theater™ was used for the preoperative planning and intraoperative 3D navigation. Preoperative and postoperative questionnaires were completed by first and second operators to get qualitative feedback on the system's functionality. Furthermore, we measured and compared the impact of this technology on surgery duration. RESULTS: Neurosurgeons were overall satisfied when using this rehearsal and navigation tool and found it efficient and easy to use; interestingly, residents considered this device more useful as compared to their more senior colleagues (with significantly higher scores, P<0.05), possibly because of their limited anatomical experience and spatial/surgical rehearsal ability. The length of the surgical procedure was not affected by this technology (P>0.05). CONCLUSIONS: Surgical Theater™ system was found to be clinically useful in improving anatomical understanding, surgical planning, and intraoperative navigation, especially for younger and less experienced neurosurgeons.

Informed consent through 3D virtual reality: a randomized clinical trial.

BACKGROUND: The informed consent is a defining moment that should allow patients to understand their condition, what procedure they are undergoing, and what consequences may follow. This process should foster trust and promote confidence, without increasing patients' anxiety. New immersive 3D imaging technologies may serve as a tool to facilitate this endeavor. METHODS: In a prospective, single-center, randomized controlled clinical trial (SPLICE Study: Surgical Planning and Informed Consent Study; ClinicalTrials.gov NCT03503487), 40 patients undergoing surgery for intracranial tumors were enrolled. After undergoing a traditional surgical informed consent acquisition, 33 patients were randomized 1:1:1 to 3 groups: in 2 experimental groups, patients underwent a 3D, immersive informed consent with two different surgical planners (group 1 and group 2); in the control group, patients underwent an informed consent supported by traditional 2D radiological images. RESULTS: Patients in the experimental groups appreciated this communication experience, while their objective comprehension was higher ((score mean (SD)): group 1 82.65 (6.83); group 2 77.76 (10.19)), as compared with the control group (57.70 (12.49); P < 0.001). Subjective comprehension and anxiety levels did not differ between experimental groups and control group. CONCLUSIONS: 3D virtual reality can help surgeons and patients in building a better relationship before surgery; immersive 3D-supported informed consent improves patients' comprehension of their condition without increasing anxiety. This new paradigm may foster trust between surgeons and patients, possibly restraining medical-legal acts. TRAIL REGISTRATION: ClinicalTrials.gov NCT03503487.