UMIN-CTR Clinical Trial

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
Email	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
Email	akuzawa-ayako@gunma.jcho.go.jp

Sponsor
Institute	Regional Medical Function Promotion Organization Gunma Central Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042480