UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043699 |
|---|---|
| Receipt number | R000049891 |
| Scientific Title | Efficacy for Prevention of Perioperative Hypothermia by Warming Both Lower Extremities During Holmium Laser Enucleation of the Prostate |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2025/03/25 12:40:52 |
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Basic information
Public title
Efficacy for Prevention of Perioperative Hypothermia by Warming Both Lower Extremities During Holmium Laser Enucleation of the Prostate
Acronym
HoLEP core temperature study
Scientific Title
Efficacy for Prevention of Perioperative Hypothermia by Warming Both Lower Extremities During Holmium Laser Enucleation of the Prostate
Scientific Title:Acronym
HoLEP core temperature study
Region
| Japan |
Condition
Condition
benign prostatic hyperplasia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Since HoLEP uses a large amount of irrigation fluid, the body temperature may drop during the surgery. We will investigate whether temperature decrease can be prevented by warming both lower limbs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core temperature at the end of surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A group of patients with a thermal blankets placed both lower limbs intraoperatively
Interventions/Control_2
A group of patients who does not wear a thermal blankets around the lower limbs intraoperatively
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
Key inclusion criteria
Patients with benign prostatic hyperplasia undergoing holmium laser enucleation of the prostate under spinal anesthesia
Key exclusion criteria
Patients undergoing holmium laser enucleation of the prostate without spinal anesthesia.
Patients who cannot obtain consent for the research.
Target sample size
165
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Yoshinuma |
Organization
Kameda Medical Center
Division name
Department of anesthesiology
Zip code
2968602
Address
929 Higasicho, Kamogawa, chiba, Japan
TEL
0470922211
yoshinuma.hiromi@kameda.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Yoshinuma |
Organization
Kameda Medical Center
Division name
Department of anesthesiology
Zip code
2968002
Address
929 Higasicho, Kamogawa, chiba, Japan
TEL
0470922211
Homepage URL
yoshinuma.hiromi@kameda.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Kameda Medical Center, Research ethics committee
Address
929 Higashicho, kamogawa, Chiba, Japan
Tel
0470922211
clinical_research@kameda.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
| 2021 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
149
Results
Covering the lower extremities with a warm blanket in addition to standard preventive measures did not show a significant difference in preventing hypothermia during transurethral HoLEP surgery.
Our results suggest that adding a warmer blanket to the lower extremities may have little contribution to preventing postoperative hypothermia.
Results date posted
| 2025 | Year | 03 | Month | 25 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Writing a Paper in English
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2021 | Year | 03 | Month | 22 | Day |
Last modified on
| 2025 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049891
