UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029092 |
|---|---|
| Receipt number | 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 19:03:50 |
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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
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
takuho@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Department of Breast and Endocrine Surgery
Institute
Department
Personal name
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
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
Value
https://center6.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 |
