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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016960
Receipt No. R000019685
Scientific Title Influence of the continuous smoke evacuation mode for patient temperature during laparoscopic surgery
Date of disclosure of the study information 2015/03/30
Last modified on 2016/10/30

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Basic information
Public title Influence of the continuous smoke evacuation mode for patient temperature during laparoscopic surgery
Acronym the continuous smoke evacuation mode for patient temperature
Scientific Title Influence of the continuous smoke evacuation mode for patient temperature during laparoscopic surgery
Scientific Title:Acronym the continuous smoke evacuation mode for patient temperature
Region
Japan

Condition
Condition laparoscopic surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We clarify whether the system with continuous smoke evacuation mode prevents a drop of the patient temperature during laparoscopic surgery.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In case of using continuous smoke evacuation mode, there are few temperature drops of the patient under the laparoscopic surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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 using continuous smoke evacuation mode
Interventions/Control_2 not using continuous smoke evacuation mode
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who receives laparoscopic surgery classified in ASA Physical status score 1 and 2
Key exclusion criteria The patient that an agreement is not provided for study entry
When body temperature is less than 35.5 degrees
Patients more than BMI35
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Sato
Organization Yokohama City University Graduate School of Medical Sciences and School of Medicine
Division name Department of Anesthesiology
Zip code
Address 3-9 Fuku-ura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL 045-787-2918
Email sjinkun@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Sato
Organization Yokohama City University Graduate School of Medical Sciences and School of Medicine
Division name Department of Anesthesiology
Zip code
Address 3-9 Fuku-ura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL 045-787-2918
Homepage URL
Email sjinkun@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medical Sciences and School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medical Sciences and School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 03 Month 30 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 Terminated
Date of protocol fixation
2015 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 29 Day
Last modified on
2016 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019685

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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