UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052210 |
|---|---|
| Receipt number | R000059582 |
| Scientific Title | Assessment of hazardous substances in surgical smoke exposed to staff in the operating room |
| Date of disclosure of the study information | 2023/09/15 |
| Last modified on | 2024/03/13 11:46:03 |
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Basic information
Public title
Assessment of hazardous substances in surgical smoke exposed to staff in the operating room
Acronym
Assessment of hazardous substances in surgical smoke exposed to staff in the operating room
Scientific Title
Assessment of hazardous substances in surgical smoke exposed to staff in the operating room
Scientific Title:Acronym
Assessment of hazardous substances in surgical smoke exposed to staff in the operating room
Region
| Japan |
Condition
Condition
Hepatobiliary and pancreatic surgical diseases requiring open laparotomy
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is known that surgical smoke generated during the use of energy devices during surgery compaunds toxic substances. We are going to verify whether the exposure of operating room staff both inside and outside the surgical field to surgical smoke is higher than the norm or not.
Basic objectives2
Others
Basic objectives -Others
Safety of operating room staff
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Volatile organic compounds in surgery smoke will be measured and compared to the exposure levels of staff in the operating room and the Ministry of Health, Labor and Welfare/WHO reference values.
Key secondary outcomes
Volatile organic compounds in surgery-related smoke will be measured and exposure levels among staff in the operating room will be compared.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Two badge-type measuring devices are attached to the chest of the primary surgeon, anesthesiologist, direct care nurse, and indirect care nurse. After 5 minutes, the instruments are removed and the collection is completed.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 20 years of age or older undergoing open surgery at the Department of Hepatobiliary and Pancreatic Surgery, The University of Tokyo Hospital. Patients who have given their own consent to this study.
Key exclusion criteria
Patients under 19 years of age. Patients who did not give consent for this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Hasegawa |
Organization
The University of Tokyo Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
hasegawa-2su@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yui |
| Middle name | |
| Last name | Sawa |
Organization
The University of Tokyo Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
ysawa-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Hasegawa Kiyoshi
Funding Source
Organization
SAKAI Clean, Health and Safety Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-3600
hy-ohrs@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
| 2023 | Year | 09 | Month | 15 | 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
| 2023 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059582
