UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047033 |
|---|---|
| Receipt number | R000053659 |
| Scientific Title | Evaluation of Particles in Surgical Smoke and Efficacy of a Smoke Evacuator |
| Date of disclosure of the study information | 2022/02/28 |
| Last modified on | 2024/03/01 17:40:08 |
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Basic information
Public title
Evaluation of Particles in Surgical Smoke and Efficacy of a Smoke Evacuator
Acronym
Evaluation of Particles in Surgical Smoke and a Smoke Evacuator
Scientific Title
Evaluation of Particles in Surgical Smoke and Efficacy of a Smoke Evacuator
Scientific Title:Acronym
Evaluation of Particles in 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 amounts of particles in surgical smoke between some types of smoke evacuators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the amount of particles in surgical smoke between some types of smoke evacuators.
Key secondary outcomes
Comparison of the amount of acetaldehyde in surgical smoke between some types of smoke evacuators.
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
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of a hose type smoke evacuator
Interventions/Control_2
Use of a pencil type smoke evacuator(0.8cm)
Interventions/Control_3
Use of a pencil type smoke evacuator(1.8cm)
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
60
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 | Yuhi |
| Middle name | |
| Last name | Yoshizaki |
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
yoshizakiy-sur@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
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 Hospital
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3815-5411
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
| 2022 | Year | 02 | Month | 28 | 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
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 02 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053659
