UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035936 |
|---|---|
| Receipt number | R000040938 |
| Scientific Title | Efficacy of a bioelectrical impedance system for evaluation of nutritional status of patients with gastrointestinal disease |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2019/02/19 16:37:05 |
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Basic information
Public title
Efficacy of a bioelectrical impedance system for evaluation of nutritional status of patients with gastrointestinal disease
Acronym
Efficacy of an in-body system for evaluation of nutritional status of patients with gastrointestinal disease
Scientific Title
Efficacy of a bioelectrical impedance system for evaluation of nutritional status of patients with gastrointestinal disease
Scientific Title:Acronym
Efficacy of an in-body system for evaluation of nutritional status of patients with gastrointestinal disease
Region
| Japan |
Condition
Condition
Patients who underwent gatrointestinal surgery at our hospital
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To understand the efficacy of an in-body bioelectrical impedance system used to evaluate nutritional status in patients with gastrointestinal disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of patients body composition
Key secondary outcomes
WBC, lymphocyte, RBC, hemoglobin, Na, K, Cl, BUN, creatinine, total protein, serum albumin, prealbumin, CT-determined skeletal muscle mass, infusion volume, dietary intake
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Nutrition status
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A patient admitted to our hospital for surgery
2) Over 20 years of age
3) Signed informed consent
Key exclusion criteria
1) A patient with an implanted pacemaker
2) Patients considered inappropriate by the study investigator
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehito Otsubo |
Organization
St. Marianna University School of Medicine
Division name
Division of Gatroenterological and General Surgery
Zip code
Address
2-16-1, Sugao, Miyamaeku, Kawasaki-shi, Kanagawa-ken
TEL
044-977-8111
otsubo@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeharu Enomoto |
Organization
St. Marianna University School of Medicine
Division name
Division of Gatroenterological and General Surgery
Zip code
Address
2-16-1, Sugao, Miyamaeku, Kawasakishi, Kanagawaken
TEL
044-977-8111
Homepage URL
takeharu@marianna-u.ac.jp
Sponsor or person
Institute
Division of Gatroenterological and General Surgery, St. Marianna University School of Medicine Hospital
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 03 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 19 | Day |
Last modified on
| 2019 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040938
| 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 |
