Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence — ROMCAPO+AI  

Surgery Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. The estimated participants is at least 64. This study will present the descriptive statistics on the collected data of the satisfaction questionnaire, NASA-TLX, and GEARS results. Categorial variables will be examined by the chi-square test or Fisher's exact test. Continuous variables will be examined by t-test or M-W test if needed. Additionally, binary regression test will be tested for multivariate analysis. ;

Related Conditions & MeSH terms

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

• NCT number: NCT06380803
• Study type: Observational
• Source: Severance Hospital
• Contact: Hyung Seok Park, MD, PhD
• Phone: +82-2-2228-2100
• Email: imgenius@yuhs.ac
• Status: Recruiting
• Start date: April 29, 2021
• Completion date: January 26, 2025