Performance of Robotic Microsurgery Systems

Robotic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06146023
• Other study ID #: 2000034951
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2023
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Anastomosis
• Microsurgery
• Robotic Surgery

Intervention

Device:
• Robotic anastomosis (Symani surgical system and RoboticScope)
Robot-assisted microvascular anastomosis on 1.0-mm-diameter silicone vessels using the Symani surgical system and RoboticScope

Procedure:
• Conventional anastomosis
Conventional microvascular anastomosis on 1.0-mm-diameter silicone vessels using conventional microsurgical instruments and conventional surgical microscope

Locations

Country	Name	City	State
Germany	University Hospital Muenster	Münster
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Yale University

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical time	Time to perform anastomosis in minutes and seconds.	Duration of anastomosis
Primary	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
Primary	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	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
Secondary	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