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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024659
Receipt No. R000027298
Scientific Title What factors affect patient's recovery after cerebral aneurysm clipping
Date of disclosure of the study information 2016/10/31
Last modified on 2019/05/03

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Basic information
Public title What factors affect patient's recovery after
cerebral aneurysm clipping
Acronym craniotomy and patient recovery
Scientific Title What factors affect patient's recovery after
cerebral aneurysm clipping
Scientific Title:Acronym craniotomy and patient recovery
Region
Japan

Condition
Condition the patients undergoing cerebral aneurysm clipping
Classification by specialty
Surgery in general Anesthesiology Neurosurgery
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to clarify the factors that affect patients recovery after cerebral aneurysm clipping
Basic objectives2 Others
Basic objectives -Others to clarify the occurrence and factors with chronic pain
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QOR 40
Key secondary outcomes SF8 WHODAS2.0 TMIG Index chronic pain sleep index

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Questionnaire
Actigraph
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 elective cerebral aneurysm clippng under general anesthesia
Seven or more days of hospitalization is expected
Key exclusion criteria post craniotomy patients
use of sedatives
Patient with mental illness or neuropathy
Patient preoperative evaluation is difficult
Target sample size 50

Research contact person
Name of lead principal investigator
1st name ida
Middle name
Last name Ida
Organization Nara Medical University
Division name Anesthesiology
Zip code 634-8523
Address 840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL 09079627114
Email nwnh0131@yahoo.co.jp

Public contact
Name of contact person
1st name ida
Middle name
Last name Ida
Organization Nara Medical University
Division name Anesthesiology
Zip code 634-8523
Address Shijo-machi 840
TEL 09079627114
Homepage URL
Email nwnh0131@yahoo.co.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization non
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 Nara Medical University
Address Shijo-machi 840
Tel 0744298902
Email nwnh0131@yahoo.co.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
2016 Year 10 Month 31 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 5
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 Terminated
Date of protocol fixation
2016 Year 10 Month 09 Day
Date of IRB
2016 Year 09 Month 25 Day
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2017 Year 03 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 31 Day
Last modified on
2019 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027298

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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