IntroductionThe Symani Surgical System undergoes scrutiny in this study as part of a series of preclinical investigations. Previous studies compared the precision of robotic-assisted anastomoses with manual techniques. This study aims to evaluate critical, histological and gross parameters at site of anastomosis and at distance in a rat model to provide insights into the safety and efficacy of robotic-assisted microsurgery, enhancing its potential for clinical adoption. Materials and MethodsExperienced microsurgeons performed arterial and venous anastomoses in sixteen Wistar rats, randomized in four treatment groups: robotic artery, robotic vein, manual artery, and manual vein. Various parameters were evaluated at two time-points (T0 and T30) on the day of the procedure and at Day 28(T28d). In the second phase of the study animals underwent necropsy, histopathologic analysis and micro-CT scans angiography imaging of anastomosis sites, major organs and distant target organs by a blinded assessor. ResultsPatency rates were 100% at T0 and T30 for all anastomoses, remaining so at T28d for the robotic subgroups, while decreasing to 87.5% for manual arterial anastomoses due to an obstructive thrombus. No evidence of clot migration. Blood flow parameters and procedure times did not significantly differ. The blinded semi-quantitative histological analysis revealed no significant disparities between robotic and manual anastomoses across various pathological indicators. No gross abnormalities were detected in musculoskeletal examinations. ConclusionThis preclinical study demonstrates the safety of the Symani Surgical System. Results suggest equivalence between robotic and manual techniques regarding thrombus formation at the anastomotic site and distal organs.
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