UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044250
Receipt number R000050536
Scientific Title Evaluation of Noxious Chemicals in Surgical Smoke and Efficacy of a Smoke Evacuator
Date of disclosure of the study information 2021/06/01
Last modified on 2023/11/19 13:20:35

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Basic information

Public title

Evaluation of Noxious Chemicals in Surgical Smoke and Efficacy of a Smoke Evacuator

Acronym

Evaluation of Surgical Smoke and a Smoke Evacuator

Scientific Title

Evaluation of Noxious Chemicals in Surgical Smoke and Efficacy of a Smoke Evacuator

Scientific Title:Acronym

Evaluation of Surgical Smoke and a Smoke Evacuator

Region

Japan


Condition

Condition

Gastrointestinal disease which needs laparotomy

Classification by specialty

Surgery in general Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of the current study is to conduct a randomized controlled trial which assesses types and amounts of noxious chemicals in surgical smoke between patients who use a smoke evacuator and patients who do not.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of the amount of acetaldehyde between patients who use a smoke evacuator and patients who do not

Key secondary outcomes

1.Comparison of the amount of formaldehyde between patients who use a smoke evacuator and patients who do not
2.Comparison of the amount of particles in surgical smoke between patients who use a smoke evacuator and patients who do not


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Use of a smoke evacuator

Interventions/Control_2

No use of a smoke evacuator

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 who are more than and equal to 20 years old and undergo laparotomy

Key exclusion criteria

Patients < 20 years old

Target sample size

40


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

Email

hasegawa-2su@h.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Yoshikuni
Middle name
Last name Kawaguchi

Organization

The University of Tokyo

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


Email

yokawaguchi-tky@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

JFE (The Japanese Foundation for Research and Promotion of Endoscopy) Grant

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

Email

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

2021 Year 06 Month 01 Day


Related information

URL releasing protocol

https://plaza.umin.ac.jp/htokyotransplant/results/index.html

Publication of results

Unpublished


Result

URL related to results and publications

Available soon, because the result is in public process.

Number of participants that the trial has enrolled

42

Results

Our randomized controlled trial showed that the use of smoke evacuator removed 70-95% of volatile organic compounds and particulate matters in surgical smoke.

Results date posted

2023 Year 11 Month 19 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Twenty years or older patients who underwent laparotomy.

Participant flow

Eligible patients who provided written informed consent were assigned in a 1:1 ratio to either an intervention (use of a smoke evacuator) or a control group.

Adverse events

None

Outcome measures

The primary endpoint was a change in the acetaldehyde level in surgical smoke.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2021 Year 04 Month 26 Day

Date of IRB


Anticipated trial start date

2021 Year 06 Month 01 Day

Last follow-up date

2022 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

2021 Year 05 Month 18 Day

Last modified on

2023 Year 11 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050536


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name