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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038220
Receipt No. 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 2019/10/07

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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 Obsterics 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

Not applicable
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
Email 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/
Email ohashi.rinri@ext.toho-u.ac.jp

Sponsor
Institute Department of Anesthesiology Toho University Ohashi Medical Center
Institute
Department

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
Email 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
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 Preinitiation
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
2019 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043572

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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