UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057784 |
|---|---|
| Receipt number | R000066041 |
| Scientific Title | Perioperative nutritional and physical function evaluation of gastric cancer surgery patients |
| Date of disclosure of the study information | 2025/05/06 |
| Last modified on | 2025/05/06 12:13:12 |
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Basic information
Public title
Perioperative nutritional and physical function evaluation of gastric cancer surgery patients
Acronym
Perioperative nutritional and physical function evaluation of gastric cancer surgery patients
Scientific Title
Perioperative nutritional and physical function evaluation of gastric cancer surgery patients
Scientific Title:Acronym
Perioperative nutritional and physical function evaluation of gastric cancer surgery patients
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
As gastric cancer patients age, the number of patients with comorbidities and those with sarcopenia and frailty is increasing. In addition, patients with advanced gastric cancer are prone to malnutrition due to reduced food intake caused by physical obstruction. Careful perioperative management (exercise and nutritional therapy) is becoming increasingly important. This study will clarify the motor function and nutritional status before and after surgery, and will identify the type of patients whose motor function and nutritional status decline as a result of gastric cancer surgery, and to what extent.
Basic objectives2
Others
Basic objectives -Others
To clarify motor function and nutritional status before and after gastric cancer surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-minute walk test
at the first consultation, preoperatively (at the time of hospitalization for surgery), at the time of discharge, 1 week, 4 weeks, and 12 weeks after surgery.
Key secondary outcomes
test data (blood count, biochemistry), body composition, grip strength, leg circumference, Bathel index, motor function evaluation (short physical performance battery)
at the first consultation, preoperatively (at the time of hospitalization for surgery), at the time of discharge, 1 week, 4 weeks, and 12 weeks after surgery.
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
Cases undergoing gastric cancer surgery
Cases in which test results and other clinical data can be provided to the research office for this study
Cases in which consent can be obtained from the patient's blood relative, parent, spouse, or guardian in cases involving minors or adults who lack the capacity to consent.
Key exclusion criteria
Patients who have not given consent
Patients who the responsible researcher or attending physician deems inappropriate
Target sample size
770
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Fujikuni |
Organization
Hiroshima Prefectural Hospital
Division name
Department of Gastroenterological Surgery
Zip code
734-8530
Address
Ujina Kanda 1-5-44
TEL
0822541818
fujikuni2292@gmail.com
Public contact
Name of contact person
| 1st name | Nobuaki |
| Middle name | |
| Last name | Fujikuni |
Organization
Hiroshima Prefectural Hospital
Division name
Department of Gastroenterological Surgery
Zip code
734-8530
Address
Ujina Kanda 1-5-44
TEL
0822541818
Homepage URL
fujikuni2292@gmail.com
Sponsor or person
Institute
Hiroshima Prefectural Hospital
Institute
Department
Personal name
Nobuaki Fujikuni
Funding Source
Organization
Hiroshima Prefectural Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima Prefectural Hospital
Address
Ujina Kanda 1-5-44
Tel
0822541818
fujikuni2292@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
広島県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational studies
Management information
Registered date
| 2025 | Year | 05 | Month | 06 | Day |
Last modified on
| 2025 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066041
