UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043830 |
|---|---|
| Receipt number | R000049997 |
| Scientific Title | Pilot Study of IoRE (Internet of Robot-surgery Education) in general thoracic surgery |
| Date of disclosure of the study information | 2021/04/05 |
| Last modified on | 2025/02/11 14:37:44 |
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Basic information
Public title
Pilot Study of IoRE (Internet of Robot-surgery Education) in general thoracic surgery
Acronym
Model of IoRE (Internet of Robot-surgery Education) in Mie University Hospital
Scientific Title
Pilot Study of IoRE (Internet of Robot-surgery Education) in general thoracic surgery
Scientific Title:Acronym
Internet of Robot-surgery Education Model : IoRE in Mie University Hospital
Region
| Japan |
Condition
Condition
Lung cancer, Mediastinal tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Aiming to build an initial education system for robotic surgery in thoracic surgery using the Internet
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the postoperative complication rates of the initial 20 cases of robot assisted thoracic surgery in newly introduced institutions
Key secondary outcomes
the number of invited proctors, the number of remote consultations / guidance, the number of visits to external facilities
the operation time, bleeding volume, thoracotomy conversion rate, and hospitalization period of the initial 20 cases
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) A surgeon who has newly introduced robotic surgery in a respiratory surgery institution or a surgeon who is already performing robotic surgery and is introducing a new model
2) Patients undergoing robotic surgery for thoracic surgery at the facility
3) Approved by the ethics review committee at the facility
4) Persons who have obtained written consent for participation in the research
Key exclusion criteria
1) Patients who are judged by the principal investigator / coordinator to be inappropriate for inclusion in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kawaguchi |
Organization
Mie University
Division name
Thoracic surgery
Zip code
514-8507
Address
2-174, EDOBASHI,Tsu
TEL
0592315021
k-gucci@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kawaguchi |
Organization
Mie University
Division name
Thoracic surgery
Zip code
5148507
Address
2-174, EDOBASHI,Tsu
TEL
0592315021
Homepage URL
k-gucci@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174, EDOBASHI,Tsu
Tel
059-231-5045
kk-sien@med.mie-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
| 2021 | Year | 04 | Month | 05 | 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
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation items at the time of registration
Collected from test data at the time of diagnosis
* Years after graduation of the surgeon scheduled to operate, number of experiences of thoracoscopic lung resection
* Annual number of institutional thoracic surgeries, including primary lung cancer and mediastinal tumor surgery
Inspection / evaluation items during the observation period
* Proctoring number, The number of his doctors invited, the number of remote consultations / guidance, and the number of visits to external facilities
* Disease name, performance status, respiratory function 1 second dose, smoking history, surgical procedure, operation time, bleeding volume, presence / absence of thoracotomy conversion, postoperative complications (Clavien-Dindo classification), postoperative hospital stay, Drain removal date
Management information
Registered date
| 2021 | Year | 04 | Month | 03 | Day |
Last modified on
| 2025 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049997
