UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028326 |
|---|---|
| Receipt number | 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 | 2020/01/22 18:18:42 |
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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
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
seiko_y1226@yahoo.co.jp
Sponsor or person
Institute
Osaka city Juso hospital
Department of Gastroenterology,Internal Medicine
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 07 | Day |
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
| 2020 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032326
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
