UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037256 |
|---|---|
| Receipt number | R000042480 |
| Scientific Title | The effect of head heat retention for the purpose of body temperature maintenance at the time of laparoscopic descent position surgery by general anesthesia-Method of optimum head heat retention maintenance- |
| Date of disclosure of the study information | 2019/07/03 |
| Last modified on | 2019/07/11 10:27:50 |
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Basic information
Public title
The effect of head heat retention for the purpose of body temperature maintenance at the time of laparoscopic descent position surgery by general anesthesia-Method of optimum head heat retention maintenance-
Acronym
The effect of head heat retention for the purpose of body temperature maintenance at the time of laparoscopic descent position surgery by general anesthesia-Method of optimum head heat retention maintenance-
Scientific Title
The effect of head heat retention for the purpose of body temperature maintenance at the time of laparoscopic descent position surgery by general anesthesia-Method of optimum head heat retention maintenance-
Scientific Title:Acronym
The effect of head heat retention for the purpose of body temperature maintenance at the time of laparoscopic descent position surgery by general anesthesia-Method of optimum head heat retention maintenance-
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We clarify the effect of head warming for the purpose of body temperature maintenance at the time of laparoscopic placement with general anesthesia and discuss about the method of the body temperature maintenance during the same operation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The core temperature monitoring system is attached to the patient's forehead, and changes in body temperature from entry to room 0, 30, 60, 90, 120 minutes until the end of surgery are group A (no head warmth) And group B (with head warmth).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A deep body temperature monitoring system is attached to the patient's forehead, and the change in body temperature from the time of admission to the end of surgery 0, 30, 60, 90, 120 minutes after surgery is observed. As a heat retention method, the anterior chest is covered with a warm air type heating device exclusive blanket, set at 43 degrees and used. Cover the face with vinyl and coat the lower leg with thermofructoleggings.
Interventions/Control_2
A deep body temperature monitoring system is attached to the patient's forehead, and the change in body temperature from the time of admission to the end of surgery 0, 30, 60, 90, 120 minutes after surgery is observed. As a heat retention method, the anterior chest is covered with a warm air type heating device exclusive blanket, set at 43 degrees and used. Cover the face with vinyl and coat the lower leg with thermofructoleggings.Furthermore, head heat retention is used together.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing laparoscopic surgery
Key exclusion criteria
Patients who had a change in technique
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Reina |
| Middle name | |
| Last name | Takeuchi |
Organization
Regional Medical Function Promotion Organization Gunma Central Hospital
Division name
Nursing department
Zip code
371-0025
Address
Gunmakenmaebashishi Kouun-cho 1 - 7 - 13
TEL
027-221-8165
akuzawa-ayako@gunma.jcho.go.jp
Public contact
Name of contact person
| 1st name | Reina |
| Middle name | |
| Last name | Takeuchi |
Organization
Regional Medical Function Promotion Organization Gunma Central Hospital
Division name
Nursing department
Zip code
371-0025
Address
Gunmakenmaebashishi Kouun-cho 1 - 7 - 13
TEL
027-221-8165
Homepage URL
akuzawa-ayako@gunma.jcho.go.jp
Sponsor or person
Institute
Regional Medical Function Promotion Organization Gunma Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Regional Medical Function Promotion Organization Gunma Central Hospital
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
Regional Medical Function Promotion Organization Gunma Central Hospital
Address
Gunmakenmaebashishi Kouun-cho 1 - 7 - 13
Tel
027-221-8165
akuzawa-ayako@gunma.jcho.go.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
| 2019 | Year | 07 | Month | 03 | 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
| 2019 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 10 | 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
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2019 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042480
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