Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence

NCT06380803 | Recruiting

• 1 other identifier: 4-2020-1385
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective study is to investigate the satisfaction, NASA-Task Load Index (TLX), and surgical proficiency of a robotic breast surgery education program using cadaver or porcine models, as well as to develop an AI-based surgical guide for utilization within the educational program in trainees for robotic breast surgery. The main question\[s\]it aims to evaluate :

• Satisfaction questionnaire of a educational program
• NASA-TLX of a educational program
• global evaluative assessment of robotic skills (GEARS) of a robotic breast surgery for surgical proficiency Participants will participate the educational program and fill out a satisfaction questionnaire and NASA-TLX. The tutor evaluates GEARS for 15 minutes at the beginning and end of training. After the development of the surgical guide based on AI, researchers will compare a training group with or without surgical guide to see the effect of the surgical guide.

Conditions

Breast Neoplasms; Surgery; Educational Problems; Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (3)

• Satisfaction questionnaire of a educational program

  (grading scale: 1-insufficient/inadequate; 2-reasonable/adequate; 3-sufficient; 4-good; 5-very good.) Participants' perceived goals for attending the course: 1. Met expectations in knowledge (theory), 2. met expectations in skill practice, 3. met knowledge requirements in theory, 4. met the essentials in skills development, 5. developed participants at skills performance. Teaching/learning environment: 6. ambience of the laboratory, 7. structure of the session, 8. pace of the session, 9. mix explanation/opportunity to practise, 10. environment \& content valuable for understanding, 11. participants' involvement, 12. development of participants' interest in the skills, 13. training adequacy. Teaching staff performance: 14. Relationship with participants, 15. enthusiasm for teaching, 16. encouragement of participants' participation, 17. clear explanations, 18. clear demonstration of each component of the skill, 19. 'feedback'

  1 day

• NASA-Task Load index of a educational program

  Hart and Staveland's NASA Task Load Index method assesses work load on five 7-point scales. Increments of high, medium and low estimates for each point result in 21 gradations on the scales. (grading scale: 1- very low; 21-very high.) 1. Mental Demand: How mentally demanding was the task? 2. Physical Demand: How physically demanding was the task? 3. Temporal Demand: How hurried or rushed was the pace of the task? 4. Performance: How successful were participants in accomplishing what participants were asked to do? 5. Effort: How hard did participants have to work to accomplish participants' level of performance? 6. Frustration: How insecure, discouraged, irritated, stressed, and annoyed were participants?

  1 day

• Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency

  The Global Evaluative Assessment of Robotic Skills assessment involves conducting an initial evaluation for 15 minutes at the beginning of the education session and a second evaluation for 15 minutes before the end of the session, evaluating the improvement in skill level based on the difference between the two evaluation scores. (grading scale: 1- very poor; 2 - poor; 3 - average; 4 - good; 5 - excellent.) 1. Depth perception : 2. bimanual dexterity: 3. efficiency: 4. force sensitivity: 5. autonomy: 6. robotic control:

  1 day

Secondary Outcomes (3)

• The comparison of satisfaction questionnaire of a educational program between the group with the surgical guide and without the surgical guide

  through study completion, an average of 4 year

• The comparison of NASA-Task Load index of a educational program between the group with the surgical guide and without the surgical guide

  through study completion, an average of 4 year

• The comparison of Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency between the group with the surgical guide and without the surgical guide

  through study completion, an average of 4 year

Interventions

A educational program OTHER

A educational program using cadaver or porcine models for robotic brest surgery

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

any breast surgeon who participate a educational program using cadavers or porcine models for robotic breast surgery

You may qualify if:

• A breast surgeon who completed the basic dry lab for surgical robot platform before the educational program
• A trainee who signed a informed consent

You may not qualify if:

• A trainee who did not sign a informed consent
• A trainees judged by the researcher to be inappropriate for participation in this study

Sponsors & Collaborators

• Severance Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Yonsei University College of Medicine

Seoul, 120-752, South Korea

RECRUITING

Related Publications (3)

• da Costa PM, Santos J, Maio R, Santos A, Paredes F. The role of a basic surgical skills laboratory as viewed by medical students (6th year). Med Teach. 2001 Mar;23(2):176-180. doi: 10.1080/01421590120036565.

  PMID: 11371295 BACKGROUND

• Goh AC, Goldfarb DW, Sander JC, Miles BJ, Dunkin BJ. Global evaluative assessment of robotic skills: validation of a clinical assessment tool to measure robotic surgical skills. J Urol. 2012 Jan;187(1):247-52. doi: 10.1016/j.juro.2011.09.032. Epub 2011 Nov 17.

  PMID: 22099993 BACKGROUND

• Wilson MR, Poolton JM, Malhotra N, Ngo K, Bright E, Masters RS. Development and validation of a surgical workload measure: the surgery task load index (SURG-TLX). World J Surg. 2011 Sep;35(9):1961-9. doi: 10.1007/s00268-011-1141-4.

  PMID: 21597890 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hyung Seok Park, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyung Seok Park, MD, PhD

CONTACT

+82-2-2228-2100; imgenius@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Surgery, Principal Investigator

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: April 24, 2024
• Study Start: April 29, 2021
• Primary Completion: January 26, 2025
• Study Completion: January 26, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

KR (1)