Validation of a User Questionnaire to Assess Surgeon Satisfaction and Perspectives on Robotic Surgical Systems (Robotic Surgeon Satisfaction Questionnaire - RSSQ)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 100
- Primary Endpoint
- Internal consistency.
Study Overview
Brief Summary
Robotic surgery represents a cornerstone for surgical treatment of different diseases. Since the Da Vinci patent expiry, several new robotic systems entered the market in the effort to spread to a greater extent the benefits of robotic surgery. Even if clinical comparison between new systems and the Da Vinci platform are currently available, there is lack of reporting about subjective perception of surgeons approaching new platforms; personal feedback on fluency and precision, ergonomics, OR communication and other items are missing.The aim of the study is to validate a practical, reproducible, and comparable instrument that can be applied in both clinical research and in the evaluation processes of newly introduced surgical robotic platforms.
Detailed Description
In recent years, the expansion of the robotic surgery landscape has been marked by the introduction of several new systems alongside the well-established Da Vinci platform. Emerging technologies such as Hugo™, Versius™, and Toumai™ offer distinct features in terms of ergonomics, system flexibility, user interface, and integration within the intraoperative workflow.
Initial comparison between new systems and the Da Vinci platform are currently available and include both clinical [1] and cost comparison [2,3]. However, there is a lack of reporting about subjective perception of surgeons approaching new platforms; personal feedback on fluency and precision, ergonomics, OR communication and other items are missing.
Some studies tried to address the issue [4-7]; however, to now, no instrument able to evaluate users' satisfaction on different robotic system is available.
Thus, there is a growing need for standardized tools capable of capturing the surgeon's subjective experience when using a specific robotic platform.
The present study aims to develop and validate a user satisfaction questionnaire for surgeons who operate with robotic systems, with the goal of assessing both qualitative and quantitative aspects related to perceived reliability and safety, movement fluency, ergonomic comfort, communication with staff, ease of setup (docking), and overall satisfaction.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Board-certified surgeons
- •At least 1 year of experience with robotic-assisted surgery
- •Signed informed consent to participate
Exclusion Criteria
- •Participants not fitting inclusion criteria
- •Unwilling to participate
Outcomes
Primary Outcomes
Internal consistency.
Time Frame: 6 months
Internal consistency: assessed using Cronbach's alpha for each domain. A threshold of α ≥ 0.70 will be considered acceptable.
Secondary Outcomes
No secondary outcomes reported