UMIN-CTR Clinical Trial

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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