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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028326
Receipt No. R000032326
Scientific Title Analysis of the effects of nutritional status before standby surgery on skeletal muscle mass,nutritional status,ADL after surgery in the elderly
Date of disclosure of the study information 2017/07/24
Last modified on 2018/01/22

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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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