UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058296 |
|---|---|
| Receipt number | R000066200 |
| Scientific Title | A Prospective Cross-Sectional Study on the Impact of Ageing on Perioperative Alterations in the Vascular Endothelial Glycocalyx |
| Date of disclosure of the study information | 2025/06/26 |
| Last modified on | 2025/06/26 20:57:19 |
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Basic information
Public title
A Prospective Cross-Sectional Study on the Impact of Ageing on Perioperative Alterations in the Vascular Endothelial Glycocalyx
Acronym
Perioperative Age-related Glycocalyx Evaluation Study
Scientific Title
A Prospective Cross-Sectional Study on the Impact of Ageing on Perioperative Alterations in the Vascular Endothelial Glycocalyx
Scientific Title:Acronym
Perioperative Glycocalyx and Aging Study
Region
| Japan |
Condition
Condition
Urological diseases requiring surgery
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
How does endothelial glycocalyx(EGC) detachment change in elderly patients who have undergone surgery compared to younger patients.
Basic objectives2
Others
Basic objectives -Others
To evaluate inflammation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoints are EGC thickness, evaluated based on the syndecan-1 value (pre-surgery and post-surgery) and blood flow images of the oral mucosa, which are markers of EGC detachment.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as requiring surgery and who underwent urological surgery.
Key exclusion criteria
Those who have notified us of their refusal to participate in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tsunehisa |
| Middle name | |
| Last name | SATO |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care
Zip code
4313192
Address
1-20-1, Handayama, Chuo, Hamamatsu, Shizuoka, Japan
TEL
0534352111
sato-tsune@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tsunehisa |
| Middle name | |
| Last name | SATO |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care
Zip code
4313192
Address
1-20-1, Handayama, Chuo, Hamamatsu, Shizuoka, Japan
TEL
0534352111
Homepage URL
sato-tsune@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Ethics Committee of Hamamatsu University School of Medicine (EC HUSM)
Address
1-20-1, Handayama, Chuo, Hamamatsu, Shizuoka, Japan
Tel
053-435-2680
rinri@hama-med.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
浜松医科大学医学部附属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 26 | 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 | 03 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analyse observation items across the board.
Management information
Registered date
| 2025 | Year | 06 | Month | 26 | Day |
Last modified on
| 2025 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066200
