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 2023/04/11 09:10:53

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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

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 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

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

2023 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name