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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043796
Receipt No. R000049918
Scientific Title The relationship between perioperative complications and the amount of un-retrieved normal saline used for irrigation during HoLEP.
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/31

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Basic information
Public title The relationship between perioperative complications and the amount of un-retrieved normal saline used for irrigation during HoLEP.
Acronym Perioperative complications during HoLEP.
Scientific Title The relationship between perioperative complications and the amount of un-retrieved normal saline used for irrigation during HoLEP.
Scientific Title:Acronym Perioperative complications during HoLEP.
Region
Japan

Condition
Condition Prostatic hyperplasia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between the amount of un-retrieved normal saline used for irrigation and perioperative complications in HoLEP
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between the amount of un-retrieved normal saline used for irrigation and the change of PaO2/FiO2 ratio
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
99 years-old >
Gender Male
Key inclusion criteria Patients who are scheduled to undergo HoLEP.
Key exclusion criteria Patients have difficult insertion of invasive arterial pressure line.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Urasawa
Middle name
Last name Masatoshi
Organization Shinshu University School of Medicine.
Division name The Department of Anesthesiology and Resuscitology
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto-shi, Nagano 390-8621, Japan
TEL 0263-37-2670
Email murasawa@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Urasawa
Middle name
Last name Masatoshi
Organization Shinshu University School of Medicine.
Division name The Department of Anesthesiology and Resuscitology
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto-shi, Nagano 390-8621, Japan
TEL 0263-37-2670
Homepage URL
Email murasawa@shinshu-u.ac.jp

Sponsor
Institute Shinshu University.
Institute
Department

Funding Source
Organization Shinshu University.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee, Shinshu University School of Medicine.
Address 3-1-1 Asahi, Matsumoto-shi, Nagano 390-8621, Japan
Tel 0263-37-2572
Email mdrinri@shinshu-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
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 Enrolling by invitation
Date of protocol fixation
2021 Year 03 Month 15 Day
Date of IRB
2021 Year 03 Month 15 Day
Anticipated trial start date
2021 Year 03 Month 15 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2021 Year 03 Month 31 Day
Last modified on
2021 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049918

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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