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| Name | Class |
|---|---|
| Yale University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Active Comparator | Conventional microsurgery with conventional microsurgical instruments and conventional surgical microscope |
|
| Robotic | Experimental | Robot-assisted microsurgery with microsurgery robot and robotic microscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic anastomosis (Symani surgical system and RoboticScope) | Device | Robot-assisted microvascular anastomosis on 1.0-mm-diameter silicone vessels using the Symani surgical system and RoboticScope |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maximilian Kückelhaus, MD | University Hospital Muenster | Principal Investigator |
| Haripriya S Ayyala, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States | ||
| University Hospital Muenster |
Primary data from this study can be made available upon request for dedicated purposes.
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Comparison of conventional manual microsurgery versus robot-assisted microsurgery
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Outcome assessors are blinded for participant groups and number of anastomosis during evaluation of scores.
| Conventional anastomosis | Procedure | Conventional microvascular anastomosis on 1.0-mm-diameter silicone vessels using conventional microsurgical instruments and conventional surgical microscope |
|
Rapid entire body assessment (REBA) to evaluate surgical ergonomics. Numeric score, low values indicate better results. |
| Evaluated right after completion of each anastomosis |
| Münster |
| 48149 |
| Germany |