Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06380803

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

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
64 (estimated)
Sponsor
Severance Hospital · Academic / Other
Sex
All
Age
Healthy volunteers

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERA educational programA educational program using cadaver or porcine models for robotic brest surgery

Timeline

Start date
2021-04-29
Primary completion
2025-01-26
Completion
2025-01-26
First posted
2024-04-24
Last updated
2024-04-24

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT06380803. Inclusion in this directory is not an endorsement.