UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058149 |
|---|---|
| Receipt number | R000066462 |
| Scientific Title | Evaluation of Risk Factors for Postoperative Delirium and Its Impact on Prognosis in Elderly Patients Using the Yamaguchi Mental Disorder Scale (YDS) and E-PASS |
| Date of disclosure of the study information | 2025/06/11 |
| Last modified on | 2025/06/11 12:50:33 |
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Basic information
Public title
Evaluation of Risk Factors for Postoperative Delirium and Its Impact on Prognosis in Elderly Patients Using the Yamaguchi Mental Disorder Scale (YDS) and E-PASS
Acronym
Evaluation of Risk Factors for Postoperative Delirium and Its Impact on Prognosis in Elderly Patients Using the Yamaguchi Mental Disorder Scale (YDS) and E-PASS
Scientific Title
Evaluation of Risk Factors for Postoperative Delirium and Its Impact on Prognosis in Elderly Patients Using the Yamaguchi Mental Disorder Scale (YDS) and E-PASS
Scientific Title:Acronym
Evaluation of Risk Factors for Postoperative Delirium and Its Impact on Prognosis in Elderly Patients Using the Yamaguchi Mental Disorder Scale (YDS) and E-PASS
Region
| Japan |
Condition
Condition
Elderly patients aged 80 years or older who underwent elective surgery for gastroenterological cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to comprehensively evaluate the risk factors for postoperative delirium in elderly patients by combining the Yamaguchi Mental Disorder Scale (YDS) and E-PASS, and to clarify the impact of preoperative cognitive impairment and the development of postoperative delirium on the prognosis of patients undergoing surgery for gastroenterological cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative survival time
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 80 years or older at the time of surgery
2.Patients who underwent elective surgery for gastrointestinal cancer (esophageal, gastric, colorectal, liver, biliary tract, or pancreatic cancer)
3.Patients who underwent preoperative evaluation using the Yamaguchi Mental Disorder Scale (YDS)
4.Patients with documented presence or absence of postoperative delirium
Key exclusion criteria
1.Patients with impaired communication ability prior to surgery (JCS score of 10 to 300)
2.Cases with evident delirium prior to surgery
3.Patients with multiple primary cancers
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836222264
hnagano@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Tokumitsu |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
7558505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836222264
Homepage URL
yt790604@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-u.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
| 2025 | Year | 06 | Month | 11 | 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
| 2025 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To reduce the risk of postoperative delirium, it is essential to appropriately assess risk factors preoperatively and implement preventive measures. However, the conventional cognitive assessment tool, the Hasegawa Dementia Scale (HDS), has been somewhat cumbersome for use in surgical wards, making rapid risk evaluation challenging. To address this issue, our department independently developed the Yamaguchi Mental Disorder Scale (YDS). Using this tool for preoperative cognitive assessment, we have attempted to identify patients at high risk of developing delirium. A previous study has shown that patients with low YDS scores are at higher risk for postoperative delirium. In addition, the Estimation of Physiologic Ability and Surgical Stress (E-PASS), a surgical risk assessment method, evaluates postoperative risk based on surgical stress and the patient's physiological status. It enables comprehensive assessment of both preoperative and intraoperative risk factors, and has also been suggested to be associated with the risk of developing delirium.
Management information
Registered date
| 2025 | Year | 06 | Month | 11 | Day |
Last modified on
| 2025 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066462
