UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of functional outcome of elderly patients admitted neurosurgical department-comparison with the frailty before onset.
Title of the study (Brief title)	Assessment of functional outcome of elderly patients admitted neurosurgical department-comparison with the frailty before onset.
Region	Japan

Condition
Condition	All neurosurgical disease
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the states of patients with frailty both beginning of treatment and end of treatment
Basic objectives2	Others
Basic objectives -Others	assessment of treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate the state of patients after one year from beginning of treatment with standard evaluation of frailty
Key secondary outcomes	modified Rankin' scale modified frailty index

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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients admitted in our neurosurgical department
Key exclusion criteria	Pateints who do not agree with participating this study
Target sample size	500

Research contact person
Name of lead principal investigator	Hidetoshi Kasuya
Organization	Tokyo Women's Medical University Medical Center East
Division name	neurosurgery
Address	2-1-10,Nishi-ogu,Arakawa-ward, Tokyo
TEL	03-3810-1111
Email	hkasuya@twmu.ac.jp

Public contact
Name of contact person	Atsushi Sasahara
Organization	Tokyo Women's Medical University Medical Center East
Division name	neurosurgery
Address	2-1-10,Nishi-ogu,Arakawa-ward, Tokyo
TEL	03-3810-1111
Homepage URL
Email	asasa7666@yahoo.co.jp

Sponsor
Institute	Tokyo Women's Medical University Medical Center East
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University Medical Center East
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 08 Month 14 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Evaluate the frailty of admitted patients in our department.

Management information
Registered date	2018 Year 09 Month 18 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038960