UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028306
Receipt number 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 17:13:32

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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 or person

Institute

Hiroshima University Hospital

Institute

Department

Personal name



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

Value
https://center6.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