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 under the COVID-19 epidemic
Date of disclosure of the study information 2021/04/05
Last modified on 2022/08/25 08:17:40

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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

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) 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 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



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

Email

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

2022 Year 08 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049997


Research Plan
Registered date File name
2021/06/13 IoRE研究計画書v1.3.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name