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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034019
Receipt No. R000038698
Scientific Title Comparison of warming effect of underbody blanket and upperbody blanket in the lithotomy position surgery under general anesthesia
Date of disclosure of the study information 2018/09/18
Last modified on 2019/04/05

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Basic information
Public title Comparison of warming effect of underbody blanket and upperbody blanket in the lithotomy position surgery under general anesthesia
Acronym Comparison of warming effect of underbody blanket and upperbody blanket in the lithotomy position surgery under general anesthesia
Scientific Title Comparison of warming effect of underbody blanket and upperbody blanket in the lithotomy position surgery under general anesthesia
Scientific Title:Acronym Comparison of warming effect of underbody blanket and upperbody blanket in the lithotomy position surgery under general anesthesia
Region
Japan

Condition
Condition Colorectal disease
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Comparison of warming effect of underbody blanket and upperbody blanket in the lithotomy position surgery under general anesthesia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraoperative central temperature
Key secondary outcomes 1. Intraoperative peripheral temperature
2. Intraoperative bleeding volume
3. Postoperative shivering
4. Postoperative complication
5. Length of hospital stays after surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Warming with an underbody blanket
Interventions/Control_2 Warming with an upperbody blanket
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 1. Age: 20 years and over
2. Gender: Male and Female
3. Anesthesia method: General anesthesia
4. Operation type: Lower gastrointestinal laparoscopic surgery
5. Patient who got document agreement with free will of patient himself / herself
Key exclusion criteria 1. Emergency operation
2. History of malignant hyperthermia
3. Drug hypersensitivity such as allergies
4. Not appropriate for the study at the physician's assessment
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Terumitsu Sawai
Organization Nagasaki University
Division name Institute of Biomedical Sciences
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8520, Japan
TEL 0958197900
Email sawai@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Hara
Organization Nagasaki University
Division name Graduate School of Biomedical Sciences Health Sciences
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8520, Japan
TEL +81958197900
Homepage URL
Email khara-opns@umin.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Nagasaki Medical Center
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
2018 Year 09 Month 18 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 Open public recruiting
Date of protocol fixation
2018 Year 08 Month 10 Day
Date of IRB
2018 Year 09 Month 03 Day
Anticipated trial start date
2018 Year 09 Month 18 Day
Last follow-up date
2019 Year 11 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
2018 Year 09 Month 04 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038698

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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