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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028306
Receipt No. R000032355
Scientific Title Single center, exploratory research of pre- and intra-operative neck warming for the prevention of peri-operative hypothermia on laparoscopic abdominal surgery
Date of disclosure of the study information 2017/07/21
Last modified on 2019/07/25

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Basic information
Public title Single center, exploratory research of pre- and intra-operative neck warming for the prevention of peri-operative hypothermia on laparoscopic abdominal surgery
Acronym Single center, exploratory research of pre- and intra-operative neck warming
Scientific Title Single center, exploratory research of pre- and intra-operative neck warming for the prevention of peri-operative hypothermia on laparoscopic abdominal surgery
Scientific Title:Acronym Single center, exploratory research of pre- and intra-operative neck warming
Region
Japan

Condition
Condition Laparoscopic abdominal surgery
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the efficacy of pre- and intra-operative neck warming for the prevention of peri-operative hypothermia on laparoscopic abdominal surgery
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes the incidence of perioperative hypothermia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Pre- and intra-operative warming by neck warmer with disposable heating pad with standard warming
Neck warmer are started about 150 min before the expected start of surgery and maintain until the end of anesthesia

Interventions/Control_2 standard warming: precordial warming with forced-air cover which is started at induction of general anesthesia and maintain until the end of anesthesia
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 1. American Society of Anesthesiologists (ASA) physical status 1,2
2. Laparoscopic abdominal surgery with an expected duration of at least 120 min
3. Combined general and epidural anesthesia
4. Written informed consent
Key exclusion criteria 1. Emergency operation
2. Without epidural anaesthesia
3. Body mass index under 18
4. Body mass index over 35
5. Preoperative fever (>38 degrees)
6. Current infection
7. Thyroid disease
8. Arteriosclerosis obliterans
9. Diabetes Mellitus
10. Using acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroid
11. Cervical central venous catheter
12. Cervical skin disorder
13. History of burns by disposable heating pad
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Ohge
Organization Hiroshima University Hospital
Division name Department of Infectous Diseases
Zip code
Address Kasumi 1-2-3, Minami-ku, Hiroshima City, Hiroshima, Japan
TEL 082-257-1613
Email ohge@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Kitagawa
Organization Hiroshima University Hospital
Division name Deparment of Gastrointestinal Surgery
Zip code
Address Kasumi 1-2-3, Minami-ku, Hiroshima City, Hiroshima, Japan
TEL 082-257-5216
Homepage URL
Email hkitaga@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 07 Month 21 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
2017 Year 07 Month 20 Day
Date of IRB
2017 Year 07 Month 20 Day
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2018 Year 12 Month 23 Day
Date of closure to data entry
2019 Year 01 Month 16 Day
Date trial data considered complete
2019 Year 02 Month 06 Day
Date analysis concluded
2019 Year 03 Month 08 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 20 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032355

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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