Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence
NCT ID: NCT06380803
Last Updated: 2024-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
64 participants
OBSERVATIONAL
2021-04-29
2025-01-26
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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A educational program
A educational program using cadaver or porcine models for robotic brest surgery
Eligibility Criteria
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Inclusion Criteria
* A trainee who signed a informed consent
Exclusion Criteria
* A trainees judged by the researcher to be inappropriate for participation in this study
ALL
No
Sponsors
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National Research Foundation of Korea
OTHER
Severance Hospital
OTHER
Responsible Party
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Hyung Seok Park, MD, PhD
Professor, Department of Surgery, Principal Investigator
Principal Investigators
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Hyung Seok Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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4-2020-1385
Identifier Type: -
Identifier Source: org_study_id
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