Component Analysis of Surgical Smoke and Evaluation of Reduction through theUse of Smoke Evacuator Devices
Research Protocol

Principal Investigator
Kiyoshi Hasegawa
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,
Graduate School of Medicine, The University of Tokyo, Tokyo, JapanTEL 03-3815-5411 ext. 37118
Emergency Contact: 090-2639-5873 FAX 03-5684-3989
E-mail: hasegawa-2su@h.u-tokyo.ac.jp

Protocol Author
Yoshikuni Kawaguchi
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,
Graduate School of Medicine, The University of Tokyo, Tokyo, JapanTEL 03-3815-5411 ext. 30381
Emergency Contact 080-7015-5656 FAX 03-5684-3989
E-mail: yokawaguchi-tky@umin.ac.jp

Study period: After approval - March 31, 2023 (Registration deadline: March 31, 2022)
March 22, 2021, First version of the plan prepared1

Title of ResearchPage
1.

Title of research

32.

Organization of the research

3

3.

Purpose and significance of the research

4

4.

Method and duration of the research55.

Selection of research subjects

7

6.

The rationale for the scientific rationale of the research

8

7.

Procedures for receiving IC

98.

Handling personal information, etc.

99.

Burden, risk, and benefit to research subjects

10

10.

Storage and disposal of samples and information

10

11.

Reporting to the head of the research institution

12

12.

Sources of funding/conflicts of interest

12

13.

Disclosure of information on research

12

14.

Consultation with research subjects

12

15.

Obtaining IC from surrogate donors

12

16.

Obtaining assent

12

17.

Confirmation of requirements for obtaining consent

13

18.

Financial burden/gratuity

13

19.

Response to serious adverse events

13

20.

Health Damage Compensation

13

21.

Provision of medical care after research is conducted

14

22.

Handling of important findings and research results

14

23.

Outsourcing of work, supervision of contractors

14

24.

Future research use of samples and information

14

25.

Monitoring and auditing

142

1. Name of researchComponent Analysis of Surgical Smoke and Evaluation of Reduction through the Useof Smoke Evacuator Devices
2. Research implementation organization
Principal Research Institution
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,
Graduate School of Medicine, The University of Tokyo, Tokyo Japan
Responsible for: Data collection, anonymization, data analysis
Collaborating Institution
Environmental Technology Center co., Ltd, Saitama, Japan
Responsible for: Analysis of surgical smoke
Research Institution
Principal Research Institution
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,
Graduate School of Medicine, The University of Tokyo
Principal Investigator: Kiyoshi Hasegawa
TEL 03-3815-5411 ext. 37118
Fax: 03-5684-3989
E-mail: hasegawa-2su@h.u-tokyo.ac.jp
Research Practice Director: Yoshikuni Kawaguchi
TEL 03-3815-5411 ext. 30381
FAX 03-5684-3989
E-mail: yokawaguchi-tky@umin.ac.jp
Research Sharing Investigator:
Yuhi Yoshizaki
Kosuke Kashiwabara
Akihiko Ichida
Takeaki Ishizawa
Nobuhisa Akamatsu
Junichi Kaneko
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Junichi Arita
All, The University of Tokyo
Collaborating Institutions:
Environmental Technology Center co., Ltd
Research Director
Toshiaki Kawakami
tel 04-2951-0150
Fax: 04-2951-0150
E-mail: kawakami@i-kankyo.com

3. Purpose and Significance of the Study[Background] It is known that smoke (surgical-related smoke) is generated when energy
devices (electrocautery, vascular coagulation devices, etc.) are used during surgery. It is
known that smoke contains toxic substances [1, 2], but it is unknown which components
and to what extent, and how much of the toxic substances in the smoke can be removed
by using surgical smoke evacuation devices that are commercially available for medical
use. Several companies sell smoke evacuation devices for medical use, but their use is
not widespread. Our operating room does not have a surgical smoke evacuation system,
and it is not used during surgery. We hypothesized that the use of surgical smoke
evacuation devices removes toxic substances from smoke, and planned a clinical study
to verify this hypothesis.
[Purpose] In this study, we will conduct a multicenter study on the types and amounts of
toxic substances in surgical smoke by randomly assigning patients to use or not to use
surgical smoke evacuation devices to verify our hypothesis and the preliminary resultsof a small number of cases. The findings of this study will lead to a wider recognition of
the harmfulness of surgical smoke and the usefulness of surgical smoke evacuation
devices and may lead to the prevention of health hazards for healthcare workers in theoperating room in the future.
[In this study, we randomly assigned patients to use or not to use surgical smoke
evacuation devices to examine the types and amounts of hazardous substances insurgical smoke to verify the hypothesis and the results of a preliminary study using asmall number of cases. The findings of this study will lead to a wider awareness of the4harmfulness of surgical smoke and the usefulness of surgical smoke evacuation devices
and may lead to the prevention of health hazards for healthcare workers in the operating
room in the future.
[References]
1. Limchantra, I. V., et al. (2019). "Surgical Smoke Exposure in Operating Room
Personnel: A Review. "JAMA Surg.
2. Al Sahaf, O. S., et al. (2007). "Chemical composition of smoke produced by highfrequency electrosurgery," Ir J Med Sci 176(3): 229-232.

4. Methods and duration of the study[Methods]
This is an observational study without invasive intervention.
The study will be conducted with those who have obtained a consent form (page 16)
after the explanation of the study is provided in the Explanation Document (pages 1315). The Consent Withdrawal Document (page 17) will also be distributed to provide an
opportunity for withdrawal after consent has been given.
2. Patients who meet the inclusion criteria and have given consent will be assigned tothe surgical smoke evacuation device use group (A) or non-use group (B) without theknowledge of the operating physician. At this point, patients will be anonymized with a"subject identification code" that will be set up at the facility to enable the linking of
subjects.
3A. Intervention group (surgical smoke evacuation system)
A surgical smoke evacuation device (Vigilia Smoke Evacuation System, model no.
VC120, ConMed) and smoke suction tube (22 mm x 3.0 m smoke evacuation tube,
model no. VTWT624, ConMed) were used (ConMed). ConMed) (Figure 1). The smoke
suction tube is placed so that the tip of the tube is 5 cm from the planned incision at thetime of laparotomy, as it is used in actual clinical practice. The surgical smoke
evacuation device is placed about 1 m away from the operating table, as used in actual
clinical practice. The smoke evacuation device is switched on at the start of thelaparotomy procedure.

5

3B. Control group (no use of surgical smoke evacuation device)
The same preparation and procedures as in 3A are performed, but the surgical smoke
evacuation device is not connected to the smoke suction tube. (This is to reduce the biasof the surgeon to know whether the smoke evacuation device is used or not.
4. A sterile cover is placed over a table (20 cm headward and 20 cm above the upperedge of the planned incision) on which a small smoke collection device is placed
approximately above the patient's face (1) Mini-pump, model number: MP-W5P,
Shibata Scientific Corporation, [Figure 2]) (2) Particle counter, model number: Model
804, Shibata Kagaku Corporation, [Figure 3]). Collect for 10 minutes from the start ofthe operation. 5.
5. The collected smoke is analyzed at the Environmental Technology Center co., Ltd
outside the university to which the co-researcher belongs, with a subject identification
code assigned.

[Period]6

Registration Period/Subject Period: From the date of approval to March 31, 2022
Institution: From the date of approval to March 31, 2023
[Anonymization]
Subjects will be anonymized by the "subject identification code" set in the institution as
described above to enable linking. The principal investigator or co-investigator at thecollaborating institution will use a "subject identification code" that is unrelated to thesubject's name and hospital ID and register the subject with that number. The code will
be used only for this study. No personally identifiable information will be used when the
results of the study are published.
[Analysis method]
The Student's t-test will be used to compare the detected amounts of acetaldehyde,
formaldehyde, and emissions by particle size in the two groups (surgical smoke
evacuation device-using group vs. non-user group).
[primary endpoint]
Quantitative measurement of acetaldehyde in surgical smoke.
To verify whether the surgical smoke evacuation device reduces the amount of theabove toxic substances.
[Secondary endpoint]
Quantitative measurement of formaldehyde in surgical smoke.
Measurement of emissions by particle size in surgical smoke (measurement by 0.3μm,
0.5μm, 1μm, and 2μm is possible).
Also, evaluate the differences in formaldehyde and particle size emissions using
surgical smoke evacuation equipment.

5. Selection of research subjects[Number of research subjects] Overall expected number of subjects: 40 cases (40 cases
at the University of Tokyo)[Selection criteria]
1. Inclusion criteria
Patients aged 20 years or older undergoing laparotomy at the primary research
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institution. Patients who have given their own consent for this study. Since the amountof surgical smoke emission during laparotomy is considered to be affected by theamount of subcutaneous fat and gender, patients will be randomly assigned to a groupwith or without surgical smoke evacuation device based on age, gender, and body massindex.
2. Exclusion Criteria
Patients under 19 years of age. Patients who did not give consent for this study.

6. Rationale for the scientific rationale of the study
Smoke generated during surgery was collected and measured for the purpose ofevaluating the operating room environment. After a close examination of the evaluation
procedure, we found that there was no process that interfered with normal medical
treatment or surgery, and that there was no invasiveness to the patient because we were
only collecting smoke generated in the operating room. After explaining the situation to
the head of the surgery department, smoke samples were collected and analyzed in theoperating room. The operating room environment was evaluated under the following
conditions: 3 patients were not using smoke evacuation devices, and 3 patients wereusing smoke evacuation devices (the smoke evacuation devices were used as samples
for clinical evaluation purposes). Toxic substances that were noticeably elevated in thesurgical smoke were formaldehyde and acetaldehyde. The results of detected amounts
by use vs. non-use of smoke evacuation devices are shown in Figure 4. Comparing theresults of the preliminary study with the guideline values of the Ministry of Health,
Labor and Welfare's "Study Group on Indoor Air Pollution Problems," it was found thatthe amount of acetaldehyde detected was higher than the guideline values. Based onthese results of the environmental assessment in the operating room, further scrutiny
was considered necessary, and this study was planned to take into account various
factors such as patients' clinical information (age, gender, body mass index, andwith/without smoke evacuation devices).
The results of environmental measurements in the same operating room wereused as a reference to calculate the sample size for this study. A sample size test was
conducted using SAS, version 9.4 (SAS Institute Inc.) to test the hypothesis that
acetaldehyde emissions, which were above the standard value, would decrease from79.2 μg/m3 to 24.6 μg/m3 when smoke evacuation devices were used, with α: 0.05 andβ: 0.1. The required number of subjects was 6 in both groups. The number of persons
required for the hypothetical decrease to the guideline value of 48 μg/m3 was 10 for
8both groups. Considering the possibility of sample collection errors, 40 patients in bothgroups will be included. Because this study also requires the collection of clinicalinformation on patients, it will be conducted after ethical review.

7. procedure for receiving IC
After patients undergoing surgery at the Department are admitted, an xplanation andconsent for this study will be obtained at the time when other Department-led researchis explained during the IC regarding surgery prior to surgery. Patients who have had thisstudy explained to them using the Explanation Document (pp. 13-16) and who haveobtained a Consent Form (p. 17) will be considered for this study. A Consent
Withdrawal Document (p. 18) will also be distributed to provide an opportunity forwithdrawal after consent is given.

8. Handling personal information
Surgical-related smoke to be dispersed during surgery will be collected, and clinicalinformation will be collected. Both will be anonymized at the University of Tokyo bycreating a correspondence table. The former will be handed directly to the co-researcher
at the University of Tokyo in anonymized form on the day the smoke is collected, andthe components will be analyzed at the Environmental Technology Center co., Ltd,
which is a joint research facility. Clinical information will be collected at the Universityof Tokyo, and this data will not be passed on to outside parties.
99. Burden, risks, and benefits to research subjects(1) Physical and psychological burden and potential risks (including cost burden, time,and information leakage)
There is no physical risk because the research will only collect smoke generated during
surgery in actual clinical practice. Although the utmost care will be taken in thehandling of personal information, there is a possibility of psychological burden in theevent of information leakage.
(2) Details of cases in which there is a benefit to the research subject
By analyzing the smoke generated during surgery and elucidating the benefits of using
smoke evacuation devices, we may be able to provide insight into the smoke that may
be passively taken in by the research subjects themselves. In addition, there is value incontributing to society by elucidating the risks associated with surgical smoke inoperating room workers through this research.
(3) Reasons why (1) is inevitable to obtain research results
Because it is essential to handle clinical information of patients (age, gender, body massindex, etc.) in order to compare and study surgery-related smoke.
(4) Measures to minimize the contents of (1)Maximum care in handling personal information.

10. Storage and disposal of samples and information
This study requires the collection of surgical smears as samples and clinical informationas materials.
[Storage and disposal of samples]
Surgical smoke
Storage location: Environmental Technology Center co., Ltd Storage
Method: Refrigerator in the Environmental Technology Center co., Ltd
Time and method of disposal: Date of smoke collection
Clinical information before anonymization
1. Clinical information
Storage location: Medical records of Hepato-Biliary-Pancreatic Surgery Division,
Department of Surgery,Graduate School of Medicine, The University of Tokyo
Storage method: In accordance with hospital regulations for medical records
10Disposal timing and method: In accordance with hospital regulations for medical
records
2. Consent and Consent Withdrawal Form
Storage location: Secretarial Office, Hepato-Biliary-Pancreatic Surgery Division,
Department of Surgery, Graduate School of Medicine, The University of Tokyo
Storage method: In a locked cabinet
Time and method of disposal: Shredded 10 years after the publication of research results
Information after anonymization and information related to the results of the analysis
Storage location
The University of Tokyo: Secretariat Office, Hepato-Biliary-Pancreatic Surgery
Division, Department of Surgery, Graduate School of Medicine, The University ofTokyo (electronically lockable)
Environmental Technology Center co., Ltd: Research room accessible only to researchpersonnel (electronically lockable)
Method of storage
The University of Tokyo: stored in a password-protected computer that cannot be taken
out.
Environmental Technology Center co., Ltd: stored on a password-protected computerthat cannot be taken out of the building.
Timing and method of disposal
The University of Tokyo: Deleted using data deletion software 10 years after
publication of research results.
Environmental Technology Center co., Ltd: 10 years after the publication of theresearch results, the data will be deleted using data deletion software.
[Correspondence table]
Storage location: Secretarial office of Hepato-Biliary-Pancreatic Surgery Division,
Department of Surgery, Graduate School of Medicine, The University of Tokyo(electronically lockable)
Method of storage: In a password-protected computer that cannot be removed from theanonymized database.
Time and method of disposal: Deleted by data deletion software 10 years after the
publication of the study results.

1111. Reporting to the head of the research institution
Although the risks in this study are not expected to be significant, reports will be madeto the head of the primary research institution in the event of unforeseen circumstances.

12. Funding source/conflict of interest
The research will be supported by a research grant from the JFE (The JapaneseFoundation for Research and Promotion of Endoscopy) Grant.
Title: "Evaluation of Toxic Substances in Surgical Smoke during Laparoscopic andOpen Surgery: Investigation of Effects on Human Health and Effectiveness of SmokeEliminating Devices to Remove Toxic Substances and Viruses", Principal Investigator:
Yoshikuni Kawaguchi
There are no conflicts of interest to report in this study.

13. Disclosure of information on the research
The results of the research will be made public through conference presentations,academic journals, domestic and international databases, etc., after anonymization.

14. Consultation with research subjects
No disclosure of individual research results will be made in response to personalinquiries, as it is unlikely that any important health findings (e.g., adverse health effects)
will be obtained that can be returned to individual research participants.

15. Obtaining informed consent from a surrogate
This study will not cover the acquisition of IC from a surrogate when it is necessary.
With regard to the withdrawal form, it will be possible for the consenter to withdraw theform.

16. Obtaining assent
Since the subjects are 20 years of age or older, this does not apply to obtaining assent
and will not be conducted.

1217. Confirmation of requirements for obtaining consent
Patients over 20 years old undergoing laparotomy in our group. Patients who have given
their own consent to this study. Exclusion criteria are patients under 19 years of age andthose who have not given their consent for this study.

18. Financial burden and honorarium
This ancillary study is a study to collect clinical information within the scope of normal
insurance treatment, and there will be no additional costs associated with participation.
There will be no increase in costs due to participation in this study.

19. Handling of serious adverse events
Not applicable as the study is based on clinical practice. In the event of a serious
adverse event caused by a drug, the responsible physician or sub-researcher will report
it in the usual way. Reporting in the usual way refers to reporting to the head of the
medical institution to which one belongs, spontaneous reporting from a medical
institution to the Pharmaceutical Affairs Bureau of the Ministry of Health, Labour andWelfare under the "Safety Information Reporting System for Drugs and Medical
Devices," a project of the Ministry of Health, Labour and Welfare, and voluntary
reporting from a medical institution to a company under the "Company Reporting
System" based on the "Law Concerning Quality, Effectiveness and Safety Assurance ofPharmaceuticals, Medical Devices and Other Products". The medical institution shallmake a voluntary report to the company based on the "Company Reporting System" inaccordance with the "Act on Quality, Efficacy and Safety Assurance of Drugs andMedical Devices, etc.".

20. Health damage compensation
Since this research will be conducted within the scope of normal insurance treatment, no
financial compensation will be provided. In the event of an adverse event in this study,
appropriate treatment will be provided in the same manner as a treatment for healthhazards in normal medical care and will involve partial co-payment by the researchsubject's medical insurance. Since this is research to collect information associated withactual clinical practice, no compensation or insurance coverage for health hazards is13

envisaged.

21. Provision of medical care after the study is conducted
Since this is an observational study that does not involve interventions conducted within
the scope of normal insurance treatment, the provision of medical care after the study isconducted will involve partial co-payment by the research subjects' medical insurance,
as appropriate treatment similar to that provided within the scope of normal clinicalpractice will be provided.

22. Handling of important findings and research results
When information is obtained that the researcher deems necessary to disclose from a
medical point of view, etc., it will be disclosed in consideration of ethical aspects. In
principle, information that has been conducted as part of medical treatment will be
disclosed. If the researcher does not wish to disclose the results, he/she will be asked to
notify us in the confirmation section of the consent form.

23. Outsourcing and supervision of contractors
This research will not be outsourced.

24. Future research use of samples and information
No secondary use of materials/information collected in this study will be made.

25. Monitoring and auditing
Monitoring and auditing will not be conducted in this study.

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