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NOT YET RECRUITING
NCT07051941

Validation of a User Questionnaire to Assess Surgeon Satisfaction and Perspectives on Robotic Surgical Systems

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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.

Official title: Validation of a User Questionnaire to Assess Surgeon Satisfaction and Perspectives on Robotic Surgical Systems (Robotic Surgeon Satisfaction Questionnaire - RSSQ)

Key Details

Gender

All

Age Range

30 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-07-01

Completion Date

2025-12-01

Last Updated

2025-07-04

Healthy Volunteers

Not specified

Conditions

Interventions

OTHER

Validation of a satisfaction questionnaire for robotic surgeon

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. 1. Test for Content Validity and Face Validity: a pilot test will be performed with 5-10 surgeons from FPG to ensure content and face validity, item comprehension, and usability. 2. Validation from external users: