Performance of Robotic Microsurgery Systems

• Sponsor: University Hospital Muenster (Other)
• Overall Status: Completed
• CT.gov ID: NCT06146023
• Collaborator: Yale University (Other)
• Enrollment: 18
• Locations: 2
• Arms: 2
• Actual Duration (Months): 9
• Patients Per Site: 9
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Robotic Surgery; Microsurgery; Anastomosis	Device: Robotic anastomosis (Symani surgical system and RoboticScope); Procedure: Conventional anastomosis	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Comparison of conventional manual microsurgery versus robot-assisted microsurgeryComparison of conventional manual microsurgery versus robot-assisted microsurgery
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcome assessors are blinded for participant groups and number of anastomosis during evaluation of scores.
• Primary Purpose: Treatment
• Official Title: Preclinical Performance of The Combined Application of Two Robotic Systems in Microsurgery
• Actual Study Start Date: Oct 1, 2022
• Actual Primary Completion Date: Jul 1, 2023
• Actual Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional Conventional microsurgery with conventional microsurgical instruments and conventional surgical microscope	Procedure: Conventional anastomosis; Conventional microvascular anastomosis on 1.0-mm-diameter silicone vessels using conventional microsurgical instruments and conventional surgical microscope
Experimental: Robotic Robot-assisted microsurgery with microsurgery robot and robotic microscope	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

Outcome Measures

Primary Outcome Measures

1. Surgical time [Duration of anastomosis]

   Time to perform anastomosis in minutes and seconds.

2. 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.

3. 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.

Secondary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale New Haven Hospital	New Haven	Connecticut	United States	06510
2	University Hospital Muenster	Münster		Germany	48149

Sponsors and Collaborators

• University Hospital Muenster
• Yale University

Investigators

• Principal Investigator: Maximilian Kückelhaus, MD, University Hospital Muenster
• Principal Investigator: Haripriya S Ayyala, MD, Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kai Wessel, Principal Investigator, University Hospital Muenster
• ClinicalTrials.gov Identifier: NCT06146023
• Other Study ID Numbers: 2000034951
• First Posted: Nov 24, 2023
• Last Update Posted: Nov 24, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Kai Wessel, Principal Investigator, University Hospital Muenster: Learning curve; Robotics; Surgical ergonomics; Surgical training

Study Results

No Results Posted as of Nov 24, 2023