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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.
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 Hugoâ„¢, Versiusâ„¢, and Toumaiâ„¢ 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.
In this evolving landscape, standardized tools are essential to assess surgeons' subjective perceptions regarding the use of specific robotic platforms. User satisfaction is a critical indicator for the adoption and effectiveness of new surgical technologies.
The aim of the study is to provide 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.
STUDY OBJECTIVE
This study aims to validate a surgeon satisfaction questionnaire for those surgeons utilizing robotic surgical systems. The goal is to evaluate qualitative and quantitative aspects related to:
The questionnaire does not represent itself a tool for the comparison of new robotic systems; however, its outcome measures are objective and could be used for the comparative evaluation of robotic systems. The questionnaire could be applied to surgeons of different disciplines (urology; general surgery; gynecology; etc).
METHODS Study Design This study follows a cross-sectional design. The primary endpoint is to validate a questionnaire to assess user satisfaction among expert surgeons utilizing various surgical robotic systems, including - but not limited to - the Da Vinci®, Hugo™ RAS, Versius®, and Toumai® platforms.
The Questionnaire has been developed from two Authors (MCS and BR) according to the following steps:
Literature Review and Domain Identification
A comprehensive literature review was conducted to identify key domains related to user satisfaction with robotic surgical systems. Major areas identified include:
Item Generation Based on these domains, an initial pool of items was generated; items were formulated as Likert-scale questions (5-point) and grouped into thematic sections. Both positive and negative phrasing was used to reduce response bias. An draft of the survey is reported as Supplementary Material.
The validation of the Questionnaire will be developed with a 2-step process.
Participants
The validation study will include a cohort of expert robotic surgeons (n = ~50-100) who have performed at least 100 robotic procedures with one or more platforms (Da Vinci®, Hugo™, etc.). Inclusion criteria:
Data Collection Surgeons will be invited to complete the questionnaire via a secure web-based platform (Survey Monkey). The on-line questionnaire will start with a brief explanation of the project and with the Informed Consent to be signed from the surgeon to participate in the study; if denied, the questionnaire will be automatically deleted. If the surgeon agrees to participates, the questionnaire will develop according to the attached Supplementary File. Demographic data (age, gender, years of robotic experience, surgical specialty, platform used) will also be collected.
Statistical analysis Reliability Analysis
Test-Retest Reliability A subgroup of surgeons (n = 20) will be asked to complete the questionnaire twice, 1-2 weeks apart. Intraclass Correlation Coefficient (ICC) will be calculated to evaluate temporal stability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgeon | The validation study will include a cohort of expert robotic surgeons (n = ~50-100) who have performed at least 100 robotic procedures with one or more platforms (Da Vinci®, Hugo™, etc.). Inclusion criteria:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Validation of a satisfaction questionnaire for robotic surgeon | Other | The primary endpoint is to validate a questionnaire to assess user satisfaction among expert surgeons utilizing various surgical robotic systems, including - but not limited to - the Da Vinci®, Hugo™ RAS, Versius®, and Toumai® platforms. Based on these domains, an initial pool of items was generated; items were formulated as Likert-scale questions (5-point) and grouped into thematic sections. The validation of the Questionnaire will be developed with a 2-step process.
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| Measure | Description | Time Frame |
|---|---|---|
| Internal consistency. | Internal consistency: assessed using Cronbach's alpha for each domain. A threshold of α ≥ 0.70 will be considered acceptable. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participant surgeons will be recruited among scientific organization/communities focused on robotic surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Chiara Sighinolfi | Contact | 0039 3921329216 | mariachiara.sighinolfi@policlinicogemelli.it | |
| Giorgia Paciotti | Contact | 3473078563 | giorgia.paciotti@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria chiara Sighinolfi | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
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