UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014735 |
|---|---|
| Receipt number | R000017129 |
| Scientific Title | Intraoperative body temperature change in Gastrointestinal surgery and Neurosurgery. Observational study |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2021/02/11 17:57:02 |
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Basic information
Public title
Intraoperative body temperature change in Gastrointestinal surgery and Neurosurgery. Observational study
Acronym
Intraoperative body temperature
Scientific Title
Intraoperative body temperature change in Gastrointestinal surgery and Neurosurgery. Observational study
Scientific Title:Acronym
Intraoperative body temperature
Region
| Japan |
Condition
Condition
Gastrointestinal surgery and Neurosurgery
Classification by specialty
| Gastrointestinal surgery | Anesthesiology | Neurosurgery |
| Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Observation of intraoperative body temperature change in our hospital
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incident of inadvertent hypothermia
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
elective surgery
Key exclusion criteria
sedative patients
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | NOBUTADA |
| Middle name | |
| Last name | MORIOKA |
Organization
Tokyo Women's Medical University
Division name
Anesthesiology
Zip code
1628666
Address
8-1 Kawadachou Shinjuku Tokyo Japan
TEL
03-3353-8111
nobutadamorioka@gmail.com
Public contact
Name of contact person
| 1st name | NOBUTADA |
| Middle name | |
| Last name | MORIOKA |
Organization
Tokyo Women's Medical University
Division name
anesthesiology
Zip code
1628666
Address
8-1 Kawadachou Shinjuku Tokyo Japan
TEL
03-3353-8111
Homepage URL
nobutadamorioka@gmail.com
Sponsor or person
Institute
Tokyo Women's Medicail University
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medicail University
Department of Anesthesiology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University
Address
8-1 Kawadachou Shinjuku Tokyo Japan
Tel
0333538111
morioka.nobutada@twmu.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
| 2014 | Year | 08 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 30 | Day |
Other
Other related information
We will get the data of body temperature during surgery as usual and add to get ambient temperature and others.
Management information
Registered date
| 2014 | Year | 08 | Month | 01 | Day |
Last modified on
| 2021 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017129
