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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2020/01/22 |
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 |
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Condition | ||||
Condition | Gastrointestinal disease,hepatobiliary pancreatic disease and breast cancer | |||
Classification by specialty |
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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
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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 |
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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. |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Osaka city Juso hospital
Department of Gastroenterology,Internal Medicine |
Institute | |
Department |
Funding Source | |
Organization | None
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |