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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032662
Receipt No. R000032800
Scientific Title Investigation of change of physical activity and function before and after operation for gastric and colorectal cancer
Date of disclosure of the study information 2018/05/21
Last modified on 2018/05/21

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Basic information
Public title Investigation of change of physical activity and function before and after operation for gastric and colorectal cancer
Acronym Investigation of change of physical activity and function before and after operation for gastric and colorectal cancer
Scientific Title Investigation of change of physical activity and function before and after operation for gastric and colorectal cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Kobayashi
Organization Southern Tohoku General Hospital
Division name Department of Surgery
Zip code
Address 7-115, Yatsuyamada, Koriyama, Fukushima
TEL 024-934-5322
Email hiroshi.kobayashi@mt.strins.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kobayashi
Organization Southern Tohoku General Hospital
Division name Department of Surgery
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 21 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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 04 Day
Date of IRB
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

Other
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

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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