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

NCT07051941 | Not Yet Recruiting

• 1 other identifier: 7809
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgery

Keywords

robotic surgery; robotic system; precision; ergonomics; safety

Outcome Measures

Primary Outcomes (1)

• Internal consistency.

  Internal consistency: assessed using Cronbach's alpha for each domain. A threshold of α ≥ 0.70 will be considered acceptable.

  6 months

Study Arms (1)

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: * Board-certified surgeons * At least 1 year of experience with robotic-assisted surgery * Informed consent to participate

Other: Validation of a satisfaction questionnaire for robotic surgeon

Interventions

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. 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:

Surgeon

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participant surgeons will be recruited among scientific organization/communities focused on robotic surgery

You may qualify if:

• Board-certified surgeons
• At least 1 year of experience with robotic-assisted surgery
• Signed informed consent to participate

You may not qualify if:

• Unwilling to participate

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Officials

• Maria chiara Sighinolfi

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Chiara Sighinolfi

CONTACT

0039 3921329216; mariachiara.sighinolfi@policlinicogemelli.it

Giorgia Paciotti

CONTACT

3473078563; giorgia.paciotti@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-06