UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045094 |
|---|---|
| Receipt number | R000051515 |
| Scientific Title | Influence of the experience of VAL-MAP on choice of procedure for early-stage lung cancer: a web-based cross-sectional study |
| Date of disclosure of the study information | 2021/08/09 |
| Last modified on | 2021/08/08 15:29:13 |
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Basic information
Public title
Influence of the experience of VAL-MAP on choice of procedure for early-stage lung cancer: a web-based cross-sectional study
Acronym
Influence of the experience of VAL-MAP on choice of procedure for early-stage lung cancer: a web-based cross-sectional study
Scientific Title
Influence of the experience of VAL-MAP on choice of procedure for early-stage lung cancer: a web-based cross-sectional study
Scientific Title:Acronym
Influence of the experience of VAL-MAP on choice of procedure for early-stage lung cancer: a web-based cross-sectional study
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of experience with Virtual-assisted lung mapping (VAL-MAP) on the choice of surgical procedure in a Web-based.
Basic objectives2
Others
Basic objectives -Others
This study aims to examine the effect of different levels of experience with VAL-MAP on a surgeon's choice of procedure for early-stage lung cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the mean score of the responses about the possibility of wedge resection for lung cancer, measured on a Likert scale (1 to 5).
Key secondary outcomes
The secondary outcomes were the type of procedure for the resection of lung cancer with sufficient margin under the following conditions: (1) where all the marking procedures are available and (2) at the actual hospital with possible limitation of marking procedure. The participants were asked to choose from four choices; wedge resection, segmentectomy, lobectomy, and others.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria for participants were (1) JACS members, (2) surgeons with at least three years of professional experience in thoracic surgery, and (3) surgeons engaged in thoracic surgery in the last three years.
Key exclusion criteria
The exclusion criteria were (1) surgeons who have not been involved in respiratory surgery for more than three years (2) Surgeons who work at our hospital. Because they were related to the surgery of the case used to question. Questions regarding inclusion criteria were asked in the invitation email as well as at the top of the survey web page.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Sato |
Organization
The University of Tokyo Graduate School of Medicine
Division name
Department of Thoracic Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
satom-sur@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Yamaguchi |
Organization
The University of Tokyo Graduate School of Medicine
Division name
Department of Thoracic Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
yamaguchih-sur@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan agency for medical research and development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Graduate School of Medicine, ethics committee
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-3815-5411
ethics@m.u-tokyo.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 | 08 | Month | 09 | 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
272
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
| 2021 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This survey was conducted from 30th April 2021 to 14 May 2021. The CONSORT diagram is shown in Figure1; An invitation to the registration to the study was sent to a total of 3139 JACS members by email and the registration was closed two weeks after the initial invitation. Between this period, a total of 374 (11.9 %) members registered for the participation and finally 276 members logged on the study website. After excluding two participants who did not meet the inclusion criteria, a total of 274 participants (8.7%) were included in the study. Two participants who logged on the website for the questionnaire did not respond to the questions at all and the remaining 272 participants responded to all the questions without missing. And therefore these 272 participants were included for a complete case analysis. Among 272 participants, 197 had no experience with VAL-MAP, 49 had experience of VAL-MAP1.0 without that of VAL-MAP2.0, and 26 had experience of VAL-MAP2.0, respectively.
Management information
Registered date
| 2021 | Year | 08 | Month | 08 | Day |
Last modified on
| 2021 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051515
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
