UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038220 |
|---|---|
| Receipt number | R000043572 |
| Scientific Title | Preoperative risk stratification based on objective functional reserve in geriatric surgical patients. |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2025/04/11 13:09:26 |
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Basic information
Public title
Preoperative risk stratification based on objective functional reserve in geriatric surgical patients.
Acronym
Perioperative functional reserve and postoperative risk
Scientific Title
Preoperative risk stratification based on objective functional reserve in geriatric surgical patients.
Scientific Title:Acronym
Perioperative functional reserve and postoperative risk
Region
| Japan |
Condition
Condition
Intraperitoneal surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Obstetrics and Gynecology |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Quantitative assessment of activity and cardiopulmonary fuction by non-invasive measurement.
Basic objectives2
Others
Basic objectives -Others
Prediction of cardiopulmonary reserve using noninvasive testing
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of perioperative mortality and morbidity
Key secondary outcomes
Length of hospital stay
Intraoperative demand and supply of oxygen
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
| 75 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Undergoing elective surgery for the treatment of intraperitoneal malignancy with laparotomy
Geriatric patients over 75 y/o
Key exclusion criteria
Patients who are unable to independently walk.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
1538515
Address
2-22-36 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
ykotake@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kawamura |
Organization
Toho University Ohashi Medical Center
Division name
Institutional review board
Zip code
1538515
Address
2-22-36 Ohashi, Meguro, Tokyo, Japan
TEL
0334681251
Homepage URL
http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
ohashi.rinri@ext.toho-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board, Toho University Ohashi Medical Center
Address
2-22-36 Ohashi, Meguro, Tokyo, Japan
Tel
0334681251
ohashi.rinri@ext.toho-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
東邦大学医療センター大橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.lab.toho-u.ac.jp/med/ohashi/anesth/research/tjoimi000000107w.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.lab.toho-u.ac.jp/med/ohashi/anesth/research/tjoimi000000107w.html
Number of participants that the trial has enrolled
0
Results
Study terminated before the subjects enrollment.
Results date posted
| 2024 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Study terminated before the subjects enrollment.
Participant flow
Study terminated before the subjects enrollment.
Adverse events
Study terminated before the subjects enrollment.
Outcome measures
Study terminated before the subjects enrollment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 31 | Day |
Other
Other related information
This observational study aims to evaluate the relationship between preoperative functional capacity, oxygen consumption and postoperative morbidity, intraoperative oxygen consumption in geriatric patients undergoing major intraperitoneal surgery.
Management information
Registered date
| 2019 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043572
