UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043796 |
|---|---|
| Receipt number | 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 | 2022/04/06 14:49:00 |
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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
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
murasawa@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University.
Institute
Department
Personal name
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
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
| 2023 | 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
| 2022 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049918
