跳至主要内容
临床试验/NCT06380803
NCT06380803招募中不适用

Surgical Skill Labs for Robotic Mastectomy Using Cadaver And Porcine Models and Educational Program Using a Surgical Guide by Artificial Intelligence

Severance Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
1
主要终点
Satisfaction questionnaire of a educational program

研究概览

简要总结

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.

详细描述

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 aims to evaluate the satisfaction questionnaire, NASA-TLX of a educational program, and 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.

The inclusion criteria is as below; a breast surgeon who completed the basic dry lab for surgical robot platform before the educational program and a trainee who signed a informed consent.

The exclusion criteria is as below; a trainee who did not sign a informed consent and a trainees judged by the researcher to be inappropriate for participation in this study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Satisfaction questionnaire of a educational program

时间窗: 1 day

(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'

NASA-Task Load index of a educational program

时间窗: 1 day

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?

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

时间窗: 1 day

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:

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyung Seok Park, MD, PhD

Professor, Department of Surgery, Principal Investigator

Severance Hospital

研究点 (1)

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