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
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
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
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
