UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of change of physical activity and function before and after operation for gastric and colorectal cancer
Title of the study (Brief title)	Investigation of change of physical activity and function before and after operation for gastric and colorectal cancer
Region	Japan

Condition
Condition	Gastric and colorectal cancer
Classification by specialty	Gastrointestinal surgery Rehabilitation medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate change of physical activity and function before and after operaton for gastric and colorectal cancer patients
Basic objectives2	Others
Basic objectives -Others	Understanding of the actual status
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Physical activity and function 1 month after operation
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patinets pathologically daiagnosed as gastric or colorectal cancer and planed to have a surgery 2)Document of agreement with eorollment
Key exclusion criteria	1)Patients who have limitation of movement 2)Patients who have severe heart or lung disease
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroshi Kobayashi
Organization	Southern Tohoku General Hospital
Division name	Department of Surgery
Address	7-115, Yatsuyamada, Koriyama, Fukushima
TEL	024-934-5322
Email	hiroshi.kobayashi@mt.strins.or.jp

Public contact
Name of contact person	Hiroshi Kobayashi
Organization	Southern Tohoku General Hospital
Division name	Department of Surgery
Address	7-115, Yatsuyamada, Koriyama, Fukushima
TEL	024-934-5322
Homepage URL
Email	hiroshi.kobayashi@mt.strins.or.jp

Sponsor
Institute	Fukushima Medical University, Department of Minimally Invasive Surgical and Medical Oncology
Institute
Department

Funding Source
Organization	Fukushima Medical University, Department of Minimally Invasive Surgical and Medical Oncology
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	2018 Year 05 Month 21 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 07 Month 04 Day
Anticipated trial start date	2017 Year 08 Month 01 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	Aim of this study is to investigate the pre-post operative physical activity ,body weight, amount of grip, walking speed, skeletal muscle mass index,and so on of patients undewent gastrectomy or colectomy.

Management information
Registered date	2018 Year 05 Month 21 Day
Last modified on	2018 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032800