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
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
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
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
