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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043699
Receipt No. 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 2021/03/22

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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
Email 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
Email yoshinuma.hiromi@kameda.jp

Sponsor
Institute Kameda Medical Center
Institute
Department

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
Email 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 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 Open public 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
2021 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049891

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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