NCT06380803|Unknown
Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence
ROMCAPO+AI
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ROMCAPO+AI
Sponsor study identifier
observational
64
1 country
1
Study Start
April 29, 2021
Actual (reported)Primary Completion
January 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 :
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2021
Actual (reported)February 28, 2024
Actual (reported)April 24, 2024
Actual (reported)January 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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?
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
A educational program using cadaver or porcine models for robotic brest surgery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
any breast surgeon who participate a educational program using cadavers or porcine models for robotic breast surgery
Yonsei University College of Medicine
Seoul, 120-752, South Korea
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.
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.
Hyung Seok Park, MD, PhD
Severance Hospital
First Submitted
February 28, 2024
First Posted
April 24, 2024
Study Start
April 29, 2021
Actual (reported)Primary Completion
January 26, 2025
Estimated (date passed)The Effects of Perioperative PECS Block During Robotic Breast Surgery and Breast Reconstruction
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
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 24, 2024
Record last verified: 2024-04
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