UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034019 |
|---|---|
| Receipt number | R000038698 |
| Scientific Title | Comparison of warming effect of underbody blanket and upperbody blanket in the lithotomy position surgery under general anesthesia |
| Date of disclosure of the study information | 2018/09/18 |
| Last modified on | 2023/12/16 10:14:27 |
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Basic information
Public title
Comparison of warming effect of underbody blanket and upperbody blanket in the lithotomy position surgery under general anesthesia
Acronym
Comparison of warming effect of underbody blanket and upperbody blanket in the lithotomy position surgery under general anesthesia
Scientific Title
Comparison of warming effect of underbody blanket and upperbody blanket in the lithotomy position surgery under general anesthesia
Scientific Title:Acronym
Comparison of warming effect of underbody blanket and upperbody blanket in the lithotomy position surgery under general anesthesia
Region
| Japan |
Condition
Condition
Colorectal disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of warming effect of underbody blanket and upperbody blanket in the lithotomy position surgery under general anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative central temperature
Key secondary outcomes
1. Intraoperative peripheral temperature
2. Intraoperative bleeding volume
3. Postoperative shivering
4. Postoperative complication
5. Length of hospital stays after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Warming with an underbody blanket
Interventions/Control_2
Warming with an upperbody blanket
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age: 20 years and over
2. Gender: Male and Female
3. Anesthesia method: General anesthesia
4. Operation type: Lower gastrointestinal laparoscopic surgery
5. Patient who got document agreement with free will of patient himself / herself
Key exclusion criteria
1. Emergency operation
2. History of malignant hyperthermia
3. Drug hypersensitivity such as allergies
4. Not appropriate for the study at the physician's assessment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Terumitsu |
| Middle name | |
| Last name | Sawai |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences
Zip code
852-
Address
1-7-1 Sakamoto, Nagasaki 852-8520, Japan
TEL
0958197900
sawai@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Hara |
Organization
Nagasaki University
Division name
Graduate School of Biomedical Sciences Health Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki 852-8520, Japan
TEL
+81958197900
Homepage URL
khara-opns@umin.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagasaki Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki 852-8520, Japan
Tel
+81958197900
khara-opns@umin.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
| 2018 | Year | 09 | Month | 18 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/33512629/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33512629/
Number of participants that the trial has enrolled
99
Results
The core temperature was significantly higher in the under group than in the upper group at 90 min after the start of surgery (p = 0.02). The peripheral temperature in the under group was significantly higher than that in the upper group 60 min after the start of surgery (p = 0.02).
On the postoperative factor, the frequency of postoperative shivering was significantly less in the under group than in the upper group (p < 0.01), and the postoperative hospital stay was significantly shortened (p = 0.04).
Results date posted
| 2020 | Year | 02 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Background: Surgery under general anesthesia results in temperature decrease due to the effect of anesthetics and peripheral vasodilation on thermoregulatory centers. Perioperative temperature control is therefore an issue of high importance. In this study, we aimed to compare the warming effect of underbody and overbody blankets in patients undergoing surgery in the lithotomy position under general anesthesia.
Participant flow
Methods: From September 2018 to October 2019, 99 patients undergoing surgery for colorectal cancer in the lithotomy position were included in this randomized controlled trial and assigned to the intervention group (underbody blanket) or control group (overbody blanket).
Adverse events
No
Outcome measures
central temperature
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 04 | Day |
Last modified on
| 2023 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038698
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/02/25 | ②研究計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/02/25 | 修士論文（データ分析）.jmp |
