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Completed

NCT Number: NCT06146023

Performance of Robotic Microsurgery Systems

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.

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Key information

Conditions

Robotic Surgery Anastomosis Microsurgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Muenster, Münster, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Conventional anastomosis

Procedure

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

Primary outcomes

  1. Surgical time

    Time frame: Duration of anastomosis

    Time to perform anastomosis in minutes and seconds.

  2. 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.

  3. 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.

Secondary outcomes

  1. Subjective Satisfaction

    Time frame: 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.

  2. Surgical ergonomics

    Time frame: Evaluated right after completion of each anastomosis

    Rapid entire body assessment (REBA) to evaluate surgical ergonomics. Numeric score, low values indicate better results.

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • Yale University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 24, 2023
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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