UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056677 |
|---|---|
| Receipt number | R000064778 |
| Scientific Title | RATS learning |
| Date of disclosure of the study information | 2025/01/14 |
| Last modified on | 2025/01/09 19:05:44 |
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Basic information
Public title
Research to investigate the challenges of acquiring and passing on lung cancer surgery skills using a surgical support robot.
Acronym
RATS learning
Scientific Title
RATS learning
Scientific Title:Acronym
RATS learning
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to validate the surgical data of robot-assisted lung lobectomy to ascertain the current state of proficiency and to identify issues in the future transfer of skills.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Learning curve by console time required for robot-assisted surgery
Key secondary outcomes
(1) Facility-wide or individual surgeon learning curve
1-1. overall time required for surgery
1-2. amount of blood loss during surgery
(2) Learning curves other than console time required
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older with clinical lung cancer or metastatic lung tumours who underwent robot-assisted lobectomy in the Department of general thoracic surgery of the Yamanashi University between November 2018 and March 2024.
Key exclusion criteria
Those with unknown details on the details of the surgical procedures.
Target sample size
154
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Uchida |
Organization
Yamanashi University
Division name
Department of general thoracic surgery
Zip code
4000845
Address
1110 Shimokato, Chuo, Yamanashi
TEL
09042058770
lucino813@gmail.com
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Uchida |
Organization
Yamanashi University
Division name
Department of general thoracic surgery
Zip code
4000845
Address
1110 Shimokato, Chuo, Yamanashi
TEL
09042058770
Homepage URL
lucino813@gmail.com
Sponsor or person
Institute
Yamanashi University
Institute
Department
Personal name
Tsuyoshi Uchida
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamanashi University
Address
1110 Shimokato Chuo, Yamanashi
Tel
0552739682
lucino813@gmail.com
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
| 2025 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
https://rinri.yamanashi.ac.jp/optout/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
154
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 | 07 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study confirms institutional proficiency in robot-assisted lung lobectomy.
Management information
Registered date
| 2025 | Year | 01 | Month | 09 | Day |
Last modified on
| 2025 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064778
