UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	sarcopenic state in preoperative patients
Title of the study (Brief title)	sarcopenic state in preoperative patients
Region	Japan

Condition
Condition	Disease undergoing surgery and rehabilitation
Classification by specialty	Anesthesiology Operative medicine Rehabilitation medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to investigate sarcopenic state in perioperative patients
Basic objectives2	Others
Basic objectives -Others	no
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	muscle mass
Key secondary outcomes	muscle strength Barthel Index

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	questionnaire
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	55 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing surgery in anesthesiology management
Key exclusion criteria	Patients who can't answer to BI. Patients who undergo re-operation in hospitalization. Patients who can't well understand Japanese Patients who can't undergo evaluation of muscle mass and strength. Patients who can't undergo rehabilitation.
Target sample size	500

Research contact person
Name of lead principal investigator	Kawaguchi Masahiko
Organization	Nara Medical University
Division name	Anestesiology
Address	840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL	0744-22-3051
Email	drjkawa@gmail.com

Public contact
Name of contact person	Kido akira
Organization	Nara Medical University
Division name	Orthopedics
Address	840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL	0744-22-3051
Homepage URL
Email	akirakid@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Nara prefecture
Organization
Division
Category of Funding Organization	Local Government
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	2016 Year 07 Month 19 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 31 Day
Anticipated trial start date	2016 Year 08 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	intervention study Everyone who meet the selection criteria in patients who underwent surgery at our facility in April 2016-March 2018 we finish to gather the patients when 600 patients were entried.

Management information
Registered date	2016 Year 07 Month 19 Day
Last modified on	2016 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024981