UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035024 |
|---|---|
| Receipt number | 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 | 2019/10/10 14:09:00 |
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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
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
hi-ikegami@sis.seirei.or.jp
Sponsor or person
Institute
Seirei hamamatsu general hospital
Institute
Department
Personal name
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
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
Completed
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
･Consider the relationship between intra-bladder pressure and posture, BMI
･Prospective observational study
Management information
Registered date
| 2018 | Year | 11 | Month | 27 | Day |
Last modified on
| 2019 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039843
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
