UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032662 |
|---|---|
| Receipt number | 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 15:21:18 |
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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
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
hiroshi.kobayashi@mt.strins.or.jp
Sponsor or person
Institute
Fukushima Medical University, Department of Minimally Invasive Surgical and Medical Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032800
