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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035936
Receipt No. 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

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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
Email 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
Email takeharu@marianna-u.ac.jp

Sponsor
Institute Division of Gatroenterological and General Surgery, St. Marianna University School of Medicine Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040938

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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