Anastomosis, Microsurgery, Robotic Surgery
Conditions
Keywords
Learning curve, Robotics, Surgical ergonomics, Surgical training
Brief summary
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
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.
Interventions
PROCEDUREConventional anastomosis
Conventional microvascular anastomosis on 1.0-mm-diameter silicone vessels using conventional microsurgical instruments and conventional surgical microscope
DEVICERobotic anastomosis (Symani surgical system and RoboticScope)
Robot-assisted microvascular anastomosis on 1.0-mm-diameter silicone vessels using the Symani surgical system and RoboticScope
Sponsors
Yale University
University Hospital Muenster
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors are blinded for participant groups and number of anastomosis during evaluation of scores.
Intervention model description
Comparison of conventional manual microsurgery versus robot-assisted microsurgery
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical time | Duration of anastomosis | Time to perform anastomosis in minutes and seconds. |
| Anastomosis quality | Evaluated right after completion of each anastomosis | Anastomosis lapse index (ALI) to evaluate the quality of each stitch. Score indicates absolute number of errors per anastomosis. Low values indicate better results. |
| Microsurgical skills | Duration of anastomosis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Satisfaction | Evaluated right after completion of each anastomosis | Satisfaction with anastomosis und robotic performance (Questionnaire). Evaluation of anastomosis and robotic devices from 1 (minimum) to 10 (maximum). High values indicate better results. |
| Surgical ergonomics | Evaluated right after completion of each anastomosis | Rapid entire body assessment (REBA) to evaluate surgical ergonomics. Numeric score, low values indicate better results. |
Countries
Germany, United States
Outcome results
None listed