UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of the effects of nutritional status before standby surgery on skeletal muscle mass,nutritional status,ADL after surgery in the elderly
Acronym	Relationship between nutritional status and postoperative ADL in older surgery patients
Scientific Title	Analysis of the effects of nutritional status before standby surgery on skeletal muscle mass,nutritional status,ADL after surgery in the elderly
Scientific Title:Acronym	Relationship between nutritional status and postoperative ADL in older surgery patients
Region	Japan

Condition
Condition	Gastrointestinal disease,hepatobiliary pancreatic disease and breast cancer
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of nutritional status of old age patients on skeletal muscle mass,nutritional status,ADL after surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	body component analysis(Product name InBody use):Preoperative versus back home after 0.5M,3M
Key secondary outcomes	hematologic biochemical test(AST,ALT,gamma-GTP,TP,Alb,T-Cho,TG,BUN,Cre,FBS,CRP,Total lymphocyte count(WBC multiplied lymphocytes%)) Life coder physical measurement

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Nutrition assessment and appropriate nutritional guidance before hospitalization. For patients judged as malnourished,administer enteral nutrient(Product name IMPACT)three times daily for a period until hospitalization.
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	Patient undergoing standby surgery in our department of surgery
Key exclusion criteria	Patients who undergo minor invasive surgery such as hernia, curative surgery against hemorrhoids Patients with history of severe cardiovascular events, severe peripheral circulatory events, serious cerebrovascular events Patient with cardiac pacemaker Patients with obviously muscle atrophy Bedridden patient
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name seiko Yamaguchi
Organization	Osaka city Juso hospital
Division name	Department of Gastroenterology,Internal Medicine
Zip code
Address	2-12-27 nonakakita,yodogawa-ku,Osaka city
TEL	06-6150-8000
Email	seiko_y1226@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name seiko Yamaguchi
Organization	Osaka city Juso hospital
Division name	Department of Gastroenterology,Internal Medicine
Zip code
Address	2-12-27 nonakakita,yodogawa-ku,Osaka city
TEL	06-6150-8000
Homepage URL
Email	seiko_y1226@yahoo.co.jp

Sponsor
Institute	Osaka city Juso hospital Department of Gastroenterology,Internal Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka City University Graduate School of Life Sciences Food and Health Science Course Nutrition Medical Science Laboratory
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	大阪市立十三市民病院（大阪府）/Osaka city Juso hospital(Osaka prefecture)

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 24 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	2017 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 24 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 21 Day
Last modified on	2018 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032326

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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