UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057520 |
|---|---|
| Receipt number | R000065700 |
| Scientific Title | Effectiveness of pre- and post-operative back heating with forced-air warming in patients undergoing laparoscopic gastrointestinal surgery: open-label randomized controlled trial |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/04/04 16:41:50 |
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Basic information
Public title
Effectiveness of pre- and post-operative back heating with forced-air warming in patients undergoing laparoscopic gastrointestinal surgery: open-label randomized controlled trial
Acronym
Effectiveness of pre- and post-operative back heating with forced-air warming in patients undergoing laparoscopic gastrointestinal surgery: open-label randomized controlled trial
Scientific Title
Effectiveness of pre- and post-operative back heating with forced-air warming in patients undergoing laparoscopic gastrointestinal surgery: open-label randomized controlled trial
Scientific Title:Acronym
Effectiveness of pre- and post-operative back heating with forced-air warming in patients undergoing laparoscopic gastrointestinal surgery: open-label randomized controlled trial
Region
| Japan |
Condition
Condition
Patients undergoing laparoscopic gastrointestinal surgery
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to compare abdominal and back heating before and after surgery using forced-air warming in patients undergoing gastrointestinal surgery and to elucidate the effect of perioperative temperature management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Central and peripheral temperatures from entering to leaving the operating room.
Key secondary outcomes
Presence or absence of shivering and sweating, presence or absence of cold and hot, average blood pressure, average heart rate.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Before and after the surgery, the intervention group receives back heating with a blanket placed under the body.
Interventions/Control_2
Before and after the surgery, the control group receives abdominal heating with a blanket placed over the body.
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. Patients over 20 years old
2. Patients with an American Society of Anesthesiologists Physical Status Classification (ASA-PS Classification) of I or II
3. Patients who provided informed consent by signing the consent form either personally or through a legally authorized representative
Key exclusion criteria
1. Robotic-assisted surgery
2. Emergency surgery
3. Patients with a fever of 37.5 degrees Celsius or higher
4. Known or suspected malignant hyperthermia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Wakisaka |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Nursing, Adult Nursing
Zip code
431-3192
Address
1-20-1, Handayama, Chuo-ku, Hamamatsu, Shizuoka
TEL
0534352828
wakisaka@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hirona |
| Middle name | |
| Last name | Ishihara |
Organization
Hamamatsu University School of Medicine
Division name
Graduate School of Medical Sciences
Zip code
431-3192
Address
1-20-1, Handayama, Chuo-ku, Hamamatsu, Shizuoka
TEL
0534352111
Homepage URL
F24002@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seirei Mikatahara General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Chuo-ku, Hamamatsu, Shizuoka
Tel
0534352680
rinri@hama-med.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
| 2025 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065700
