Preclinical Performance of The Combined Application of Two Robotic Systems in Microsurgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Robotic Surgery
- Sponsor
- University Hospital Muenster
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Anastomosis quality
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Kai Wessel
Principal Investigator
University Hospital Muenster
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Anastomosis quality
Time Frame: 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
Time Frame: 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.
Surgical time
Time Frame: Duration of anastomosis
Time to perform anastomosis in minutes and seconds.
Secondary Outcomes
- Subjective Satisfaction(Evaluated right after completion of each anastomosis)
- Surgical ergonomics(Evaluated right after completion of each anastomosis)