UMIN-CTR Clinical Trial

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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