The goal of this preclinical trial is to learn about the benefits and limitations of novel robotic devices for microsurgery, based on different levels of microsurgical experience. The main questions it aims to answer are: Is robot-assisted microsurgery faster, better and more ergonomic than conventional microsurgery in a preclinical standardized setting? Participants will perform microvascular anastomoses on 1.0-mm-diameter artificial silicone vessels using a conventional manual approach versus a novel robot-assisted approach. Researchers will compare the performance of novices, advanced participants and experts to evaluate the role of microsurgical experience when learning the new technique.
Recent advancements in the development of robotic devices increasingly draw the attention towards the concept of robotic microsurgery, as several systems tailored to open microsurgery are being introduced. This study describes the combined application of a novel microsurgical robot, the Symani, with a novel robotic microscope, the RoboticScope, for the performance of microvascular anastomoses in a two-center preclinical trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
18
Robot-assisted microvascular anastomosis on 1.0-mm-diameter silicone vessels using the Symani surgical system and RoboticScope
Conventional microvascular anastomosis on 1.0-mm-diameter silicone vessels using conventional microsurgical instruments and conventional surgical microscope
Yale New Haven Hospital
New Haven, Connecticut, United States
University Hospital Muenster
Münster, Germany
Surgical time
Time to perform anastomosis in minutes and seconds.
Time frame: Duration of anastomosis
Anastomosis quality
Anastomosis lapse index (ALI) to evaluate the quality of each stitch. Score indicates absolute number of errors per anastomosis. Low values indicate better results.
Time frame: Evaluated right after completion of each anastomosis
Microsurgical skills
Structured assessment of microsurgery skills (SAMS) to evaluate microsurgical skill acquisition. Score includes 8 items evaluated from 1 (minimum) to 5 (maximum). High values indicate better results.
Time frame: Duration of anastomosis
Subjective Satisfaction
Satisfaction with anastomosis und robotic performance (Questionnaire). Evaluation of anastomosis and robotic devices from 1 (minimum) to 10 (maximum). High values indicate better results.
Time frame: Evaluated right after completion of each anastomosis
Surgical ergonomics
Rapid entire body assessment (REBA) to evaluate surgical ergonomics. Numeric score, low values indicate better results.
Time frame: Evaluated right after completion of each anastomosis
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