Performance of Robotic Microsurgery Systems

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Preclinical Performance of The Combined Application of Two Robotic Systems in Microsurgery

Conditions
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Robotic Surgery, Microsurgery, Anastomosis

Intervention / Treatment
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* Device: Robotic anastomosis (Symani surgical system and RoboticScope)
* Procedure: Conventional anastomosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Novices: no prior experience in microsurgery Residents: 2-4 years of experience in microsurgery Experts: at least 5 years of experience in microsurgery Exclusion Criteria: previous training with the robotic devices applied in this study contraindications for usage of robotic devices (magnetic field)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of conventional manual microsurgery versus robot-assisted microsurgery
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional<br>Conventional microsurgery with conventional microsurgical instruments and conventional surgical microscope | Procedure: Conventional anastomosis<br>* Conventional microvascular anastomosis on 1.0-mm-diameter silicone vessels using conventional microsurgical instruments and conventional surgical microscope<br>|
| Experimental: Robotic<br>Robot-assisted microsurgery with microsurgery robot and robotic microscope | Device: Robotic anastomosis (Symani surgical system and RoboticScope)<br>* Robot-assisted microvascular anastomosis on 1.0-mm-diameter silicone vessels using the Symani surgical system and RoboticScope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time | Time to perform anastomosis in minutes and seconds. | 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. | 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. | Duration of anastomosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Evaluated right after completion of each anastomosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Learning curve, Robotics, Surgical ergonomics, Surgical training