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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035024
Receipt No. R000039843
Scientific Title Changes in intra-bladder pressure in the supine position, lateral position and prone position for adult inpatients under scheduled surgery of Oblique lateral interbody fusion : prospective cohort study
Date of disclosure of the study information 2019/01/01
Last modified on 2019/05/29

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Basic information
Public title Changes in intra-bladder pressure in the supine position, lateral position and prone position for adult inpatients under scheduled surgery of Oblique lateral interbody fusion : prospective cohort study
Acronym Changes in intra-bladder pressure depending on posture
Scientific Title Changes in intra-bladder pressure in the supine position, lateral position and prone position for adult inpatients under scheduled surgery of Oblique lateral interbody fusion : prospective cohort study
Scientific Title:Acronym Changes in intra-bladder pressure depending on posture
Region
Japan

Condition
Condition Adult inpatients undergoing scheduled operation of Oblique lateral interbody fusion
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine whether the intra-bladder pressure in the prone position and lateral position is within the safe range
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intra-bladder pressure in the prone position and lateral position
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

Not applicable
Gender Male and Female
Key inclusion criteria Urethral catheter inserted, among adult inpatients undergoing scheduled operation of Oblique lateral interbody fusion.
Key exclusion criteria Do not insert urethral catheter or urinary tract infection suspected,among adult inpatients undergoing scheduled operation of Oblique lateral interbody fusion.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yoshie
Middle name
Last name Toba
Organization Seirei hamamatsu general hospital
Division name Anesthesiology
Zip code 4308558
Address Sumiyoshi 2-12-12 Naka-ku, Hamamatsu City Shizuoka prefecture
TEL 053-474-2222
Email yoshtoba@sis.seirei.or.jp

Public contact
Name of contact person
1st name Hiromi
Middle name
Last name Ikegami
Organization Seirei hamamatsu general hospital
Division name Anesthesiology
Zip code 4308558
Address Sumiyoshi 2-12-12 Naka-ku, Hamamatsu City Shizuoka prefecture
TEL 053-474-2222
Homepage URL
Email hi-ikegami@sis.seirei.or.jp

Sponsor
Institute Seirei hamamatsu general hospital
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 Seirei General Hospital
Address Sumiyoshi 2-12-12 Naka-ku, Hamamatsu City Shizuoka prefecture
Tel 053-474-2222
Email m-kimata@sis.seirei.or.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
2019 Year 01 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 01 Month 01 Day
Date of IRB
2018 Year 11 Month 20 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information ´ŻąConsider the relationship between intra-bladder pressure and posture, BMI

´ŻąProspective observational study

Management information
Registered date
2018 Year 11 Month 27 Day
Last modified on
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039843

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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