UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040790 |
|---|---|
| Receipt number | R000045850 |
| Scientific Title | Efficacy of a novel neck-warming device in preventing perioperative hypothermia during laparoscopic colorectal surgery: a pilot study |
| Date of disclosure of the study information | 2020/06/17 |
| Last modified on | 2021/05/17 15:34:28 |
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Basic information
Public title
Efficacy of a novel neck-warming device in preventing perioperative hypothermia during laparoscopic colorectal surgery: a pilot study
Acronym
Efficacy of a novel neck-warming device in preventing perioperative hypothermia
Scientific Title
Efficacy of a novel neck-warming device in preventing perioperative hypothermia during laparoscopic colorectal surgery: a pilot study
Scientific Title:Acronym
Efficacy of a novel neck-warming device in preventing perioperative hypothermia
Region
| Japan |
Condition
Condition
Patients undergoing elective laparoscopic colorectal surgery
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To invesigate the efficacy of a novel neck-warming device in preventing perioperative hypothermia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of patients who did not show perioperative hypothermia (core temperature < 36 degrees)
Key secondary outcomes
Perioperative core temperature, Area under the curve of perioperative core temperature, Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Neck warming during entire perioperative period from prewarming in the surgical ward until leaving the operation room. Neck prewarming start in the patients room 60 minutes before leaving to the operating room.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
20-80 years of age at the time of agreement to participate, American Society of Anesthesiologists physical status I or II, surgical procedures scheduled for more than 2 hours, undergoing elective laparoscopic colorectal surgery under epidural and eneral anesthesia that was scheduled as the first surgery of the day
Key exclusion criteria
Emergency surgery patient, body mass index <18 kg/m2 or >35 kg/m2, evidence of current infection, known metabolic disorders (e.g., hyperthyroidism or hypothyroidism), known inflammatory bowel disease, current medications interfering with normal thermoregulation (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs, or steroids), the presence of a peripherally inserted central venous catheter, the presence of skin or soft tissue disorders in areas to be covered with the neck warmer, or a history of burn by hot packs.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Ohge |
Organization
Hiroshima University Hospital
Division name
Department of infection diseases
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL
0822571613
ohge@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kitagawa |
Organization
Hiroshima University
Division name
Department of infection diseases
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL
0822571613
Homepage URL
hkitaga@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital, Department of infection diseases
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital, Department of infectious diseases
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Independent Ethics Committee, Hiroshima University Hospital
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, JAPAN
Tel
082-257-5907
iryo-seisaku@office.hiroshima-u.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
| 2020 | Year | 06 | Month | 17 | 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
| 2020 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2020 | Year | 06 | Month | 16 | Day |
Last modified on
| 2021 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045850
