An observational study in Breast Neoplasms, Surgery and Educational Problems, sponsored by Severance Hospital. Recruiting at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Severance Hospital · Observational
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 :
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 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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 64 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Severance Hospital is the lead sponsor of 51 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
any breast surgeon who participate a educational program using cadavers or porcine models for robotic breast surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A educational program using cadaver or porcine models for robotic brest surgery
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'
Time frame: 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?
Time frame: 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:
Time frame: 1 day
The comparison of satisfaction questionnaire of a educational program between the group with the surgical guide and without the surgical guide
The investigators will conduct descriptive statistical analysis of satisfaction questionnaire of a educational program. When conducting subgroup analysis within all subjects between the group with the surgical guide group and the group without the surgical guide, univariate and multivariate analysis will be performed, and the analysis will be conducted in accordance with general statistical processing. The detailed scale of the satisfaction questionnaire of a educational program is the same as the primary outcome measures.
Time frame: 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
The investigators will conduct descriptive statistical analysis of NASA-Task Load index of a educational program. When conducting subgroup analysis within all subjects between the group with the surgical guide group and the group without the surgical guide, univariate and multivariate analysis will be performed, and the analysis will be conducted in accordance with general statistical processing. The detailed scale of NASA-Task Load index of a educational program is the same as the primary outcome measures.
Time frame: 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
The investigators will conduct descriptive statistical analysis of Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency. When conducting subgroup analysis within all subjects between the group with the surgical guide group and the group without the surgical guide, univariate and multivariate analysis will be performed, and the analysis will be conducted in accordance with general statistical processing. The detailed scale of Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency is the same as the primary outcome measures.
Time frame: through study completion, an average of 4 year
Started Apr 2021 (actual). Primary completion is estimated for Jan 2025, 44 months after the start.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 44 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
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