UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057629 |
|---|---|
| Receipt number | R000065840 |
| Scientific Title | New Medical Strategy for an Aging Society: Yamagata University School of Medicine and Yamagata City Health Point Project to Achieve Zero Perioperative Complications |
| Date of disclosure of the study information | 2025/04/16 |
| Last modified on | 2025/10/27 21:56:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
New Medical Strategy for an Aging Society: Yamagata University School of Medicine and Yamagata City Health Point Project to Achieve Zero Perioperative Complications
Acronym
New Medical Strategy for an Aging Society: Yamagata University School of Medicine and Yamagata City Health Point Project to Achieve Zero Perioperative Complications
Scientific Title
New Medical Strategy for an Aging Society: Yamagata University School of Medicine and Yamagata City Health Point Project to Achieve Zero Perioperative Complications
Scientific Title:Acronym
New Medical Strategy for an Aging Society: Yamagata University School of Medicine and Yamagata City Health Point Project to Achieve Zero Perioperative Complications
Region
| Japan |
Condition
Condition
Patients undergoing surgery in the operating room of Yamagata University Hospital
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is said that moderate exercise on a regular basis is good for preventing perioperative complications. Yamagata City, on the other hand, has been working to become an advanced city for health and medical care by accumulating health points through healthy activities such as walking. The goal is to establish safer perioperative management in an aging society through collaboration between medical professionals involved in the perioperative period and the government.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of complications within 90 days post-surgery ((Clavien-Dindo classification 2 or higher))
Key secondary outcomes
One-year survival rate after surgery,length of hospital stay, quality of life indicators, medical costs, Severity of complications that occurred (Clavien-Dindo classification)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
The SUKSK application will be introduced to the planned surgery patients after obtaining their consent at the time of outpatient or inpatient admission, and the SUKSK ID information will be provided.
Interventions/Control_2
No intervention
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The health point program SUKSK targets people 18 years of age and older.
Although it is assumed that elderly people may have difficulty operating the application, we believe that it is not a good idea to divide people by age in view of the growing health consciousness.
Since some users of the health point program SUKSK are over 80 years old, we set the upper age limit to 100 years old.
Key exclusion criteria
Patients under 18 years old
Patients with cognitive impairment or communication difficulties
Patients who have expressed their refusal to participate in this study
Patients who are unable to obtain consent from the patient or a surrogate.
Patients who have difficulty participating in SUKSK (e.g., lack of Internet access, inability to use smartphones, etc.)
Patients who are unable to walk on their own
Patients who are unable to participate in SUKSK (e.g., no Internet access, no access to smartphones, etc.)
Patients who are unable to ambulate on their own
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | hiroaki |
| Middle name | |
| Last name | toyama |
Organization
Yamagata University School of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata City
TEL
0236285400
yarimizu.kenya@gmail.com
Public contact
Name of contact person
| 1st name | kenya |
| Middle name | |
| Last name | yarimizu |
Organization
Yamagata University School of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata City
TEL
0236285400
Homepage URL
yarimizu.kenya@gmail.com
Sponsor or person
Institute
Yamagata University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Health Promotion Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University School of Medicine Ethics Review Committee
Address
2-2-2 Iida-Nishi, Yamagata City
Tel
0236285400
yarimizu.kenya@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 16 | 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
| 2024 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2025 | Year | 04 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065840
