Breast NeoplasmsROMCAPO+AINCT06380803
Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence
An observational study of Breast Neoplasms and Surgery, run by Severance Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms, Surgery, Educational Problems
- What is being tested?
- A educational program
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Apr 2021to 26 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: any breast surgeon who participate a educational program using cadavers or porcine models for robotic breast surgery
Who may be able to join
- A breast surgeon who completed the basic dry lab for surgical robot platform before the educational program
- A trainee who signed a informed consent
Who cannot join
- A trainee who did not sign a informed consent
- A trainees judged by the researcher to be inappropriate for participation in this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University College of Medicine
Seoul, 120-752
Hyung Seok Park, MD, PhD, +82-2228-2100, imgenius@yuhs.ac
About this study
Official title: Surgical Skill Labs for Robotic Mastectomy Using Cadaver And Porcine Models and Educational Program Using a Surgical Guide by Artificial Intelligence
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 :
Read more
- 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.
Read the 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.
- Being tested
- A educational program
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A educational programOther
A educational program using cadaver or porcine models for robotic brest surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Met expectations in knowledge (theory),
- met expectations in skill practice,
- met knowledge requirements in theory,
- met the essentials in skills development,
- developed participants at skills performance. Teaching/learning environment:
- ambience of the laboratory,
- structure of the session,
- pace of the session,
- mix explanation/opportunity to practise,
- environment \& content valuable for understanding,
- participants' involvement,
- development of participants' interest in the skills,
- training adequacy. Teaching staff performance:
- Relationship with participants,
- enthusiasm for teaching,
- encouragement of participants' participation,
- clear explanations,
- clear demonstration of each component of the skill,
- 'feedback'
Measured: 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.)
- Mental Demand: How mentally demanding was the task?
- Physical Demand: How physically demanding was the task?
- Temporal Demand: How hurried or rushed was the pace of the task?
- Performance: How successful were participants in accomplishing what participants were asked to do?
- Effort: How hard did participants have to work to accomplish participants' level of performance?
- Frustration: How insecure, discouraged, irritated, stressed, and annoyed were participants?
Measured: 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.)
- Depth perception :
- bimanual dexterity:
- efficiency:
- force sensitivity:
- autonomy:
- robotic control:
Measured: 1 day
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start29 Apr 2021
- Primary completion26 Jan 2025 (estimated)
- Study completion26 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Hyung Seok Park, MD, PhD, Severance Hospital
- Investigators
- Hyung Seok Park, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380803
- Sponsor's protocol ID
- 4-2020-1385
- Acronym
- ROMCAPO+AI
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11371295Goh 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.
PubMed 22099993Wilson 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.
PubMed 21597890
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Skill Labs for Robotic Mastectomy Using Cadaver And Porcine Models and Educational Program Using a Surgical Guide by Artificial Intelligence
- ClinicalTrials.gov ID
- NCT06380803
- Acronym / sponsor ID
- ROMCAPO+AI / 4-2020-1385
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 26 Jan 2025 (estimated)
- Study completion
- 26 Jan 2025 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- any breast surgeon who participate a educational program using cadavers or porcine models for robotic breast surgery
Key inclusion criteria (2 listed)
- A breast surgeon who completed the basic dry lab for surgical robot platform before the educational program
- A trainee who signed a informed consent
Key exclusion criteria (2 listed)
- A trainee who did not sign a informed consent
- A trainees judged by the researcher to be inappropriate for participation in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A educational programA educational program using cadaver or porcine models for robotic brest surgery | Other | – |
Primary outcome
Satisfaction questionnaire of a educational program
Time frame: 1 day
(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'
NASA-Task Load index of a educational program
Time frame: 1 day
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?
Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency
Time frame: 1 day
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:
3 secondary outcomes
The comparison of satisfaction questionnaire of a educational program between the group with the surgical guide and without the surgical guide
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
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
Time frame: through study completion, an average of 4 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 11371295da 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.
- Background: PubMed 22099993Goh 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.
- Background: PubMed 21597890Wilson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyung Seok Park, MD, PhD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Surgery, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyung Seok Park, MD, PhD (+82-2-2228-2100, imgenius@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction questionnaire of a educational program (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06380803, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.