UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055807 |
|---|---|
| Receipt number | R000063664 |
| Scientific Title | Efficacy of "OITORE" shadowing in training for robotic surgery |
| Date of disclosure of the study information | 2024/10/11 |
| Last modified on | 2025/10/12 17:10:53 |
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Basic information
Public title
Efficacy of "OITORE" shadowing in training for robotic surgery
Acronym
Efficacy of "OITORE" shadowing in training for robotic surgery
Scientific Title
Efficacy of "OITORE" shadowing in training for robotic surgery
Scientific Title:Acronym
Efficacy of "OITORE" shadowing in training for robotic surgery
Region
| Japan |
Condition
Condition
Medical students and residents (PGY1-2)
Classification by specialty
| Surgery in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy of "OITORE" shadowing in basic skill acquisition for robotic surgery. Training of robotic skills using OITORE is compared with normal training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in time required for completing the suturing task
Key secondary outcomes
Suturing score assessed by A-LAP mini:
air pressure leakage (kPa),
number of full-thickness sutures (/3 stitches),
suture tension (%),
wound opening area (mm2)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
30 minute training for suturing tasks with "OITORE" shadowing and 30 minute training for suturing tasks with robotic simulator, 2days per week
Interventions/Control_2
60 minute training for suturing tasks with robotic simulator, 2days per week
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
1) Kyoto University medical students and residents(PGY1-2) working at Kyoto University Hospital
2) Those who have given consent to participate in this study
Key exclusion criteria
1) Those who have had surgical training with "OITORE" shadowing
2) Those who have had intensive training with a robotic simulator
3) Those judged otherwise to be unsuitable for participation in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Obama |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Surgery
Zip code
606-8507
Address
54 Shogoin-Kawahara-Cho, Sakyo-Ku, Kyoto
TEL
075-751-3650
kobama@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Okamura |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Surgery
Zip code
606-8507
Address
54 Shogoin-Kawahara-Cho, Sakyo-Ku, Kyoto
TEL
075-366-7595
Homepage URL
rokamura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
SYSMEX CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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 | 10 | Month | 11 | 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
30
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
| 2024 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 11 | Day |
Last modified on
| 2025 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063664
