UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054081 |
|---|---|
| Receipt number | R000061755 |
| Scientific Title | Comparison of Surgical Anatomy Education Using an Artificial Intelligence Surgical Vision System versus Conventional. |
| Date of disclosure of the study information | 2024/04/06 |
| Last modified on | 2025/03/26 20:22:21 |
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Basic information
Public title
Validation Study on the Effectiveness of AI Surgical Education
Acronym
AI Surgical Education Study
Scientific Title
Comparison of Surgical Anatomy Education Using an Artificial Intelligence Surgical Vision System versus Conventional.
Scientific Title:Acronym
AI Surgical Education Study
Region
| Japan |
Condition
Condition
Educational Effects of AI
Classification by specialty
| Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An artificial intelligence (AI) system that predicts anatomical structures in real time has the potential to improve surgical anatomy education. Therefore, a randomized clinical trial is needed to compare the group educated by the AI Surgical Vision System (AISVS) (AISVS group) with the conventional method (control group).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative evaluation of the improvement in the concordance rate between test images annotated by medical students for the pancreatic region and ground truth images annotated by surgeons, using the Dice coefficient to assess group differences before and after practical training. The evaluation will be conducted after the completion of the training.
Key secondary outcomes
Quantitative evaluation of the improvement in the concordance rate between test images annotated by medical students for the pancreatic region and ground truth images annotated by surgeons, using recall and precision to assess group differences before and after practical training. The evaluation will be conducted after the completion of the training.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Medical students will observe surgical images with integrated AISVS that provides real-time enhancement of the pancreatic region. They will also receive conventional educational guidance from surgical tutors during the operation.
Interventions/Control_2
Students will observe the identical surgical images as those viewed by surgeons. They will also receive conventional educational guidance from surgical tutors during the operation.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
5th year medical student
Key exclusion criteria
Exclusion criteria include students who have repeated an academic year, those who were absent from or unable to complete the practical training, and instances where no cases of distal gastrectomy or total gastrectomy were available during the training period.
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | HISASHI |
| Middle name | |
| Last name | SHINOHARA |
Organization
Hyogo Medical University
Division name
Department of Gastroenterological Surgery, Division of Upper G.I. Surgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6111
ei-nakao@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Eiichiro |
| Middle name | |
| Last name | Nakao |
Organization
Hyogo Medical University
Division name
Department of Gastroenterological Surgery, Division of Upper G.I. Surgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6726
Homepage URL
ei-nakao@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University, Ethics Review Board
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
Tel
0798-45-6111
ei-nakao@hyo-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
82
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyzed images annotated on surgical images on a PC by 5th-year medical students who participated in surgical observation training at Hyogo Medical University between April 1, 2023 and March 1, 2024.
Management information
Registered date
| 2024 | Year | 04 | Month | 06 | Day |
Last modified on
| 2025 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061755
