UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020243
Receipt number R000023373
Scientific Title Attempt of quantitative evaluation of laryngeal movement before and after esophageal surgery
Date of disclosure of the study information 2015/12/21
Last modified on 2017/07/14 15:09:49

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Basic information

Public title

Attempt of quantitative evaluation of laryngeal movement before and after esophageal surgery

Acronym

Attempt of quantitative evaluation of laryngeal movement before and after esophageal surgery

Scientific Title

Attempt of quantitative evaluation of laryngeal movement before and after esophageal surgery

Scientific Title:Acronym

Attempt of quantitative evaluation of laryngeal movement before and after esophageal surgery

Region

Japan


Condition

Condition

esophageal cancer

Classification by specialty

Gastrointestinal surgery Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Before and after esophageal surgery, to quantitatively evaluate the laryngeal movement during swallowing.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

RSST(repetitive saliva swallowing test)
MWST(modified water swallowing test)
the elevation distance of the larynx during swallowing
the elevation time of the larynx during swallowing

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

The diagnosis of esophageal cancer have been obtained by the histology.

Surgical indications

No severe complication

Written informed concent

A case of oral intake is allowed.

Key exclusion criteria

Esophagus bypass surgery

There is a risk of aspiration.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junko Fujitani

Organization

National Center for Global Health and Medicine

Division name

Department of Rehabilitaion Medicine

Zip code


Address

1-21-1 toyama shinzyuku-ku, Tokyo

TEL

03-3202-7181

Email

jufujita@hosp.ncgm.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junko Fujitani

Organization

National Center for Global Health and Medicine

Division name

Department of Rehabilitaion Medicine

Zip code


Address

1-21-1 toyama shinzyuku-ku, Tokyo

TEL

03-3202-7181

Homepage URL


Email

jufujita@hosp.ncgm.go.jp


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

No

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

No


Other related organizations

Co-sponsor

No

Name of secondary funder(s)

No


IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1

No

Study ID_2


Org. issuing International ID_2

No

IND to MHLW

なし


Institutions

Institutions

国立国際医療研究センター


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 21 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

After esophageal cancer surgery, subjects needed to place jaws on the examination table of the equipment used in this study for measurement, but it was found that this movement was difficult and stopped. Although the research itself was discontinued, it is useful that after the operation of the esophageal cancer surgery, it was difficult for the subject to have a knowledge that even a slight movement of the jaw would be difficult, possibly causing aspiration.

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

Terminated

Date of protocol fixation

2015 Year 12 Month 20 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 21 Day

Last follow-up date

2017 Year 02 Month 10 Day

Date of closure to data entry

2017 Year 02 Month 28 Day

Date trial data considered complete

2017 Year 02 Month 28 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information

The design of this study is a cohort observational study.This study, before esophageal cancer surgery, is performed on patients there was a request preoperative rehabilitation, including the swallowing function support to the Department of Rehabilitation Medicine (However esophagus bypass surgery patients are excluded).This study is carried out for the cases allowed as study from the attending physician.Recruitment period is from January 2016 to June 2016.Up to six months is the observation period after surgery.
Item to be measured is RSST(repetitive saliva swallowing test),MWST(modified water swallowing test),the elevation distance of the larynx during swallowing and the elevation time of the larynx during swallowing.


Management information

Registered date

2015 Year 12 Month 17 Day

Last modified on

2017 Year 07 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023373


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name