Performance of Robotic Microsurgery Systems

Not Applicable

Completed

• Conditions: Robotic Surgery; Microsurgery; Anastomosis
• Interventions: Procedure: Conventional anastomosis; Device: Robotic anastomosis (Symani surgical system and RoboticScope)

• Registration Number: NCT06146023
• Lead Sponsor: University Hospital Muenster

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.

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-16
• Last Update Submitted: 2023-11-16
• Study First Posted: 2023-11-24
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	Conventional anastomosis	Conventional microsurgery with conventional microsurgical instruments and conventional surgical microscope
Robotic	Robotic anastomosis (Symani surgical system and RoboticScope)	Robot-assisted microsurgery with microsurgery robot and robotic microscope

Primary Outcome Measures

Name	Time	Method
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.
Surgical time	Duration of anastomosis	Time to perform anastomosis in minutes and seconds.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

University Hospital Muenster; 🇩🇪 Münster, Germany