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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043830
Receipt No. R000049997
Scientific Title Pilot Study of IoRE (Internet of Robot-surgery Education) in general thoracic surgery under the COVID-19 epidemic
Date of disclosure of the study information 2021/04/05
Last modified on 2021/04/03

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Basic information
Public title Pilot Study of IoRE (Internet of Robot-surgery Education) in general thoracic surgery under the COVID-19 epidemic
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 under the COVID-19 epidemic
Scientific Title:Acronym Model of IoRE (Internet of Robot-surgery Education) 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) Being a facility that has newly introduced robotic surgery in thoracic surgery
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
Email 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
Email k-gucci@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University
Institute
Department

Funding Source
Organization Mie University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 0592315021
Email k-gucci@clin.medic.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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 25 Day
Date of IRB
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
2021 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049997

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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