UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050733 |
|---|---|
| Receipt number | R000057785 |
| Scientific Title | Evaluation of dysphagia in the perioperative period of gastric cancer and study of postoperative pneumonia prevention effect by active rehabilitation support |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/03/30 09:58:15 |
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Basic information
Public title
Evaluation of dysphagia in the perioperative period of gastric cancer and study of postoperative pneumonia prevention effect by active rehabilitation support
Acronym
Evaluation of dysphagia in the perioperative period of gastric cancer and study of postoperative pneumonia prevention effect by active rehabilitation support
Scientific Title
Evaluation of dysphagia in the perioperative period of gastric cancer and study of postoperative pneumonia prevention effect by active rehabilitation support
Scientific Title:Acronym
Evaluation of dysphagia in the perioperative period of gastric cancer and study of postoperative pneumonia prevention effect by active rehabilitation support
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Geriatrics | Gastrointestinal surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively examine the relationship between dysphagia and postoperative pneumonia in elderly gastric cancer patients. In addition, we will clarify the preventive effect of dysphagia and postoperative pneumonia by actively supporting rehabilitation not only during hospitalization but also after discharge.
Basic objectives2
Others
Basic objectives -Others
Pneumonia is likely to occur after surgery for gastric cancer in the elderly. Several papers have retrospectively studied the factors of gastric cancer postoperative pneumonia, and recently, sarcopenia has attracted attention as a factor of postoperative pneumonia. In gastric cancer postoperative patients, functional impairment of swallowing-related muscles due to complication of sarcopenic dysphagia in addition to normal sarcopenia due to factors such as systemic inflammation associated with disease or surgery, decreased oral intake, etc. , it is thought that aspiration pneumonia has occurred.
In this study, we will evaluate dysphagia in elderly gastric cancer patients before and after surgery using various tools and analyze the relationship with postoperative pneumonia. In addition, active rehabilitation support not only during hospitalization but also during outpatient visits is expected to lead to the prevention of dysphagia and postoperative pneumonia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before surgery and 1 month, 3 months, 6 months, and 12 months after surgery, we will conduct tests on whole body muscle mass, grip strength, physical ability, swallowing function, swallowing muscle strength, swallowing muscle mass, and respiratory muscle function. The effects of these test results and other background factors on the development of postoperative pneumonia will be analyzed using the Cox proportional hazards model.
Key secondary outcomes
In addition to the conventional perioperative period, post-discharge physical therapy and dysphagia therapy are performed on an outpatient basis for patients who wish. Analyze whether there is a difference in the incidence of pneumonia compared to before.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
For those patients who wish, we will continue physical therapy and dysphagia therapy not only in the conventional perioperative period but also outpatient after discharge.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients scheduled to undergo surgery for gastric cancer at the Kawasaki Medical School Hospital Gastroenterological Surgery.
2) Patients who are 65 years or older at the time of surgery.
3) Patients who have obtained written consent from the person himself or his representative.
Key exclusion criteria
Patients deemed inappropriate by the attending physician.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | Endo |
Organization
Kawasaki Medical School
Division name
Department of Digestive Surgery
Zip code
701-0192
Address
577, Matsushima, Kurashiki, Okayama
TEL
0864621111
endo-s@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Shunji |
| Middle name | |
| Last name | Endo |
Organization
Kawasaki Medical School
Division name
Department of Digestive Surgery
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama
TEL
0864621111
Homepage URL
endo-s@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 Matsushima, Kurashiki, Okayama
Tel
+81864621111
kmsrec@med.kawasaki-m.ac.jp
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
| 2023 | Year | 04 | Month | 01 | 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
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 31 | Day |
Last modified on
| 2024 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057785
