UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000033151