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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038680
Receipt No. R000043889
Scientific Title Are the checklist and the flowchart usueful after decrease of wave amplitude on intraoperative spinal cord monitoring?
Date of disclosure of the study information 2020/04/01
Last modified on 2021/06/28

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Basic information
Public title Are the checklist and the flowchart usueful after decrease of wave amplitude on intraoperative spinal cord monitoring?
Acronym multicenter study in Japanese spinal cord monitoring working group
Scientific Title Are the checklist and the flowchart usueful after decrease of wave amplitude on intraoperative spinal cord monitoring?
Scientific Title:Acronym multicenter study in Japanese spinal cord monitoring working group
Region
Japan

Condition
Condition spine and spinal cord disorders
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the purpose of this study is to clarify the usefulness of flowchart and checklist on intraopeartive spinal cord monitoring
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to clarify the factor of decrease of wave amplitude on intraopeartive spinal cord monitoring
Key secondary outcomes the number of rescue cases

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria all kind of spine surgery under intraoperative spinal cord monitoring
Key exclusion criteria spine surgery without intraoperative spinal cord monitoring
the case which refuse to join this study
Target sample size 2200

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Shigematsu
Organization Nara Medical University
Division name Dept. of Orthop. Surgery
Zip code 6348522
Address 840 shijocho Kashihara city
TEL 0744223051
Email shideki@naramed-u.ac.jp

Public contact
Name of contact person
1st name Hideki
Middle name
Last name Shigematsu
Organization Nara Medical University
Division name Dept. of Orthop. Surgery
Zip code 6348522
Address 840 shijocho Kashihara city
TEL 0744223051
Homepage URL
Email shideki@naramed-u.ac.jp

Sponsor
Institute monitoring WG on Japanese society for spine surgery and related research
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 Nara Medical University
Address 840 shijocho Kashihara city Nara Japan
Tel 0744-22-3051
Email shideki@naramed-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
2020 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 Open public recruiting
Date of protocol fixation
2019 Year 11 Month 25 Day
Date of IRB
2019 Year 12 Month 18 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
2023 Year 03 Month 31 Day
Date analysis concluded
2024 Year 03 Month 31 Day

Other
Other related information observation study
to clarify the utility of non-technical skill using checklist and flow chart

Management information
Registered date
2019 Year 11 Month 25 Day
Last modified on
2021 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043889

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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