Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence (ROMCAPO+AI)

April 21, 2024 updated by: Hyung Seok Park, MD, PhD, Severance Hospital

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 :

  • 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hyung Seok Park, MD, PhD
  • Phone Number: +82-2-2228-2100
  • Email: imgenius@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

any breast surgeon who participate a educational program using cadavers or porcine models for robotic breast surgery

Description

Inclusion Criteria:

  • A breast surgeon who completed the basic dry lab for surgical robot platform before the educational program
  • A trainee who signed a informed consent

Exclusion Criteria:

  • A trainee who did not sign a informed consent
  • A trainees judged by the researcher to be inappropriate for participation in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'
1 day
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?
1 day
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:
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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.
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 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.
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

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.
through study completion, an average of 4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Severance Hospital

Collaborators

National Research Foundation of Korea

Investigators

  • Principal Investigator: Hyung Seok Park, MD, PhD, Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2021

Primary Completion (Estimated)

January 26, 2025

Study Completion (Estimated)

January 26, 2025

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

April 21, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 21, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2020-1385

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Clinical Trials on A educational program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe