UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023754
Receipt number R000027246
Scientific Title Investigation of the coughing power before and after the cancer of the liver operation
Date of disclosure of the study information 2016/08/25
Last modified on 2016/08/24 22:45:49

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Basic information

Public title

Investigation of the coughing power before and after the cancer of the liver operation

Acronym

Investigation of the coughing power before and after the cancer of the liver operation

Scientific Title

Investigation of the coughing power before and after the cancer of the liver operation

Scientific Title:Acronym

Investigation of the coughing power before and after the cancer of the liver operation

Region

Japan


Condition

Condition

liver cancer

Classification by specialty

Hepato-biliary-pancreatic surgery Rehabilitation medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the extent of changes in cough peak flow after liver operation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

cough peak flow

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

The patient who is indicated for a cancer of the liver operation

Key exclusion criteria

he symptoms of critical complications, such as a shock by bleeding

When he is forced to re-intubation

Progression to a neurological symptom

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Hamada

Organization

Kansai Medical University Hospital

Division name

Division of Rehabilitation

Zip code


Address

2-3-1 Shinmachi,HirakataShi,Osaka,Japan

TEL

0708040101

Email

hamadash0602@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Hamada

Organization

Kansai Medical University Hospital

Division name

Division of Rehabilitation

Zip code


Address

2-3-1 Shinmachi,HirakataShi,Osaka,Japan

TEL

0708040101

Homepage URL


Email

hamadash0602@yahoo.co.jp


Sponsor or person

Institute

Kansai Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

Kansai Medical University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 25 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

2016 Year 08 Month 25 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 25 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Whether CPF of post-operation depend on it of pre-operation


Management information

Registered date

2016 Year 08 Month 24 Day

Last modified on

2016 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027246


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name