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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001480
Receipt No. R000001794
Scientific Title Examination of the usefulness of supplementary enteral nutrition management using an elemental diet after gastric cancer surgery
Date of disclosure of the study information 2008/11/04
Last modified on 2010/01/29

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Basic information
Public title Examination of the usefulness of supplementary enteral nutrition management using an elemental diet after gastric cancer surgery
Acronym Examination of the usefulness of elemental diet after gastric cancer surgery
Scientific Title Examination of the usefulness of supplementary enteral nutrition management using an elemental diet after gastric cancer surgery
Scientific Title:Acronym Examination of the usefulness of elemental diet after gastric cancer surgery
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the effect of long-term enteral nutrition on improving the nutritional status and QOL.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Tolerance of oral intake of an elemental diet
Key secondary outcomes Physical measurement, biochemical tests
Food intake
QOL evaluation

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Elental: over 300Kcal/day
In total of one year administration of Elental
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who had undergone gastrectomy mainly for gastric cancer
Patients assessed by the attending physician to be suitable for inclusion
Key exclusion criteria Patients with severe diabetes, and patients suspected to have abnormal sugar metabolism because of being given high doses of steroids
Patients in the first 3 months of pregnancy, and patients planning to become pregnant and receiving 5000 IU/day or more of vitamin A
Patients with abnormal amino acid metabolism
Patients with mental disorders
Patients assessed by the attending physician to be unsuitable for inclusion
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshifumi Inoue
Organization Kawasaki Hospital
Division name Head, Department of Surgery Administration
Zip code
Address 3-3-1 Higashiyama-cho, Hyogo-ku, Kobe, Hyogo 652-0042 Japan
TEL 078-511-3131
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kamigaki
Organization Kobe University Graduate School of Medicine
Division name Division of Gastrointestinal Surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017 Japan
TEL 078-382-5111
Homepage URL http://www.med.kobe-u.ac.jp/surg1/index.html
Email

Sponsor
Institute Division of Gastrointestinal Surgery, Kobe University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2008 Year 11 Month 04 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 Terminated
Date of protocol fixation
2008 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2014 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 11 Month 03 Day
Last modified on
2010 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001794

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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