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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029092
Receipt No. R000033151
Scientific Title Environmental research using a surgical smoke evacuation system in an operation room
Date of disclosure of the study information 2017/09/13
Last modified on 2019/04/01

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Basic information
Public title Environmental research using a surgical smoke evacuation system in an operation room
Acronym Environmental research using a surgical smoke evacuation system in an operation room
Scientific Title Environmental research using a surgical smoke evacuation system in an operation room
Scientific Title:Acronym Environmental research using a surgical smoke evacuation system in an operation room
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluating the efficiency of surgical smoke evacuation systems
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Measuring items in the operating rooms:
1. Volatile Organic Compounds (VOC)
2. Formaldehyde
3. Dust
4. Temperature and humidity

Measuring items for doctors and nurses:
1. Volatile Organic Compounds (VOC)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Surgical smoke evacuators on (Study group)
Interventions/Control_2 Surgical smoke evacuators off (Control group)
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 Surgeons, anesthesia professionals, and perioperative nurses in the operating rooms of planned breast cancer surgery
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Tokuda
Organization Tokai University School of Medicine
Division name Department of Breast and Endocrine Surgery
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa, Japan
TEL 0463-93-1121
Email tokuda@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name Takuho
Middle name
Last name Okamura
Organization Tokai University School of Medicine
Division name Department of Breast and Endocrine Surgery
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa, Japan
TEL 0463-93-1121
Homepage URL
Email takuho@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine
Department of Breast and Endocrine Surgery
Institute
Department

Funding Source
Organization Tokai University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional review board for clinical research, Tokai university
Address 143 Shimokasuya, Isehara, Kanagawa
Tel 0463-93-1121
Email tokai-rinsho@ml.tokai-u.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 東海大学医学部付属病院 (神奈川県)/ Tokai University Hospital

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 13 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 Enrolling by invitation
Date of protocol fixation
2015 Year 04 Month 25 Day
Date of IRB
2015 Year 05 Month 26 Day
Anticipated trial start date
2015 Year 06 Month 04 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 11 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033151

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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