UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of a bioelectrical impedance system for evaluation of nutritional status of patients with gastrointestinal disease
Title of the study (Brief title)	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	Takehito Otsubo
Organization	St. Marianna University School of Medicine
Division name	Division of Gatroenterological and General Surgery
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	Takeharu Enomoto
Organization	St. Marianna University School of Medicine
Division name	Division of Gatroenterological and General Surgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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