UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research of QOL after gastric resection
Title of the study (Brief title)	Research of QOL after gastric resection
Region	Japan

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

Objectives
Narrative objectives1	research of nutritional factors and QOL after surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL score by questionnaire of 1 year after surgery
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Patients undergoing gastrectomy
Key exclusion criteria	cases of Cardiac pacemaker placement
Target sample size	200

Research contact person
Name of lead principal investigator	Yasuyuki Seto
Organization	The University of Tokyo hospital
Division name	department of gastrointestinal surgery
Address	Hongo7-3-1, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	seto-tky@umin.ac.jp

Public contact
Name of contact person	Koichiro Kawasaki
Organization	The University of Tokyo hospital
Division name	department of gastrointestinal surgery
Address	Hongo7-3-1, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	kokawasaki-ncd@umin.ac.jp

Sponsor
Institute	The University of Tokyo hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 31 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 10 Month 26 Day
Anticipated trial start date	2016 Year 10 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	evaluate the patients after gastric resection by Measurement of QOL score by questionnaire, body composition analysis and blood test.

Management information
Registered date	2016 Year 10 Month 31 Day
Last modified on	2016 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028355