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

NCT07051941 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-07-04

No results posted yet for this study

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.

Conditions

  • Surgery

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:

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Maria chiara Sighinolfi · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-10-01
Completion
2025-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07051941 on ClinicalTrials.gov