Clinical trial NCT06380803: Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence
Official title: Surgical Skill Labs for Robotic Mastectomy Using Cadaver And Porcine Models and Educational Program Using a Surgical Guide by Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
Surgery
Educational Problems
Surgical Procedure, Unspecified
Lead sponsor: Severance Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2024-04-24
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any breast surgeon who participate a educational program using cadavers or porcine models for robotic breast surgery

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction questionnaire of a educational program
timeFrame: 1 day
measure: NASA-Task Load index of a educational program
timeFrame: 1 day
measure: Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency
timeFrame: 1 day
Secondary outcomes:
measure: The comparison of satisfaction questionnaire of a educational program between the group with the surgical guide and without the surgical guide
timeFrame: through study completion, an average of 4 year
measure: The comparison of NASA-Task Load index of a educational program between the group with the surgical guide and without the surgical guide
timeFrame: through study completion, an average of 4 year
measure: 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
timeFrame: through study completion, an average of 4 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Hyung Seok Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.