UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of a novel neck-warming device in preventing perioperative hypothermia during laparoscopic colorectal surgery: a pilot study
Acronym	Efficacy of a novel neck-warming device in preventing perioperative hypothermia
Scientific Title	Efficacy of a novel neck-warming device in preventing perioperative hypothermia during laparoscopic colorectal surgery: a pilot study
Scientific Title:Acronym	Efficacy of a novel neck-warming device in preventing perioperative hypothermia
Region	Japan

Condition
Condition	Patients undergoing elective laparoscopic colorectal surgery
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To invesigate the efficacy of a novel neck-warming device in preventing perioperative hypothermia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of patients who did not show perioperative hypothermia (core temperature < 36 degrees)
Key secondary outcomes	Perioperative core temperature, Area under the curve of perioperative core temperature, Safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Neck warming during entire perioperative period from prewarming in the surgical ward until leaving the operation room. Neck prewarming start in the patients room 60 minutes before leaving to the operating room.
Interventions/Control_2
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	20-80 years of age at the time of agreement to participate, American Society of Anesthesiologists physical status I or II, surgical procedures scheduled for more than 2 hours, undergoing elective laparoscopic colorectal surgery under epidural and eneral anesthesia that was scheduled as the first surgery of the day
Key exclusion criteria	Emergency surgery patient, body mass index <18 kg/m2 or >35 kg/m2, evidence of current infection, known metabolic disorders (e.g., hyperthyroidism or hypothyroidism), known inflammatory bowel disease, current medications interfering with normal thermoregulation (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs, or steroids), the presence of a peripherally inserted central venous catheter, the presence of skin or soft tissue disorders in areas to be covered with the neck warmer, or a history of burn by hot packs.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Ohge
Organization	Hiroshima University Hospital
Division name	Department of infection diseases
Zip code	734-8551
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL	0822571613
Email	ohge@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Kitagawa
Organization	Hiroshima University
Division name	Department of infection diseases
Zip code	734-8551
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL	0822571613
Homepage URL
Email	hkitaga@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital, Department of infection diseases
Institute
Department

Funding Source
Organization	Hiroshima University Hospital, Department of infectious diseases
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	Independent Ethics Committee, Hiroshima University Hospital
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, JAPAN
Tel	082-257-5907
Email	iryo-seisaku@office.hiroshima-u.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	2020 Year 06 Month 17 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	Enrolling by invitation
Date of protocol fixation	2020 Year 04 Month 22 Day
Date of IRB	2020 Year 05 Month 28 Day
Anticipated trial start date	2020 Year 06 Month 15 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	2020 Year 06 Month 16 Day
Last modified on	2021 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045850