Performance of Robotic Microsurgery Systems

University Hospital Muenster

Status: Completed

Conditions: Microsurgery; Anastomosis; Robotic Surgery

Treatments: Device: Robotic anastomosis (Symani surgical system and RoboticScope); Procedure: Conventional anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT06146023

2000034951

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

18 participants in 2 patient groups

Conventional

Active Comparator group

Description:

Conventional microsurgery with conventional microsurgical instruments and conventional surgical microscope

Treatment:

Procedure: Conventional anastomosis

Robotic

Experimental group

Description:

Robot-assisted microsurgery with microsurgery robot and robotic microscope

Treatment:

Device: Robotic anastomosis (Symani surgical system and RoboticScope)