UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047722
Receipt number R000054409
Scientific Title Comparison of importance of preoperative anesthesia difficulty factors affecting postoperative outcome
Date of disclosure of the study information 2022/05/11
Last modified on 2023/05/11 09:19:50

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Basic information

Public title

Comparison of importance of preoperative anesthesia difficulty factors affecting postoperative outcome

Acronym

Comparison of importance of preoperative anesthesia difficulty factors affecting postoperative outcome

Scientific Title

Comparison of importance of preoperative anesthesia difficulty factors affecting postoperative outcome

Scientific Title:Acronym

Comparison of importance of preoperative anesthesia difficulty factors affecting postoperative outcome

Region

Japan


Condition

Condition

Elective surgery patients who died within 60 days after surgery

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We will select patients who have difficulty in preoperative anesthesia and who died within 60 days and investigate which complications most affect outcome after surgery.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Select patients who have difficulty preoperative anesthesia and die within 60 days to investigate which preoperative complications have the greatest impact on postoperative outcomes

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Elective surgery patients who died within 60 days after surgery

Key exclusion criteria

emergency surgery

Target sample size

250


Research contact person

Name of lead principal investigator

1st name MAIKO
Middle name
Last name SATOMOTO

Organization

toho University

Division name

Department of Anesthesiology

Zip code

1438541

Address

6-11-1. Omori-nishi, Ota-ku, Tokyo 143-8541, Japan

TEL

09034444882

Email

maiko.satomoto@med.toho-u.ac.jp


Public contact

Name of contact person

1st name MAIKO
Middle name
Last name SATOMOTO

Organization

Toho University

Division name

Department of Anesthesiology

Zip code

1438541

Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan

TEL

0337654151

Homepage URL


Email

maiko.satomoto@med.toho-u.ac.jp


Sponsor or person

Institute

Toho University

Institute

Department

Personal name



Funding Source

Organization

Toho University, Department of Anesthesiology

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

Toho University Ethics Review Board

Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan

Tel

0337624151

Email

omori.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森病院


Other administrative information

Date of disclosure of the study information

2022 Year 05 Month 11 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

45

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

Completed

Date of protocol fixation

2020 Year 05 Month 01 Day

Date of IRB

2020 Year 07 Month 22 Day

Anticipated trial start date

2022 Year 05 Month 11 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational Study


Management information

Registered date

2022 Year 05 Month 11 Day

Last modified on

2023 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054409


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name