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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020243
Receipt No. 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

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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
Institute National Center for Global Health and Medicine
Institute
Department

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
URL(English) https://upload.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


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