UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029409 |
|---|---|
| Receipt number | R000032649 |
| Scientific Title | An observational study to evaluate the relasionship between swalloing function and swalloing pressure in a Patient after recontractive operation of Oral cancer |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2017/10/04 00:43:30 |
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Basic information
Public title
An observational study to evaluate the relasionship between swalloing function and swalloing pressure in a Patient after recontractive operation of Oral cancer
Acronym
The study of swalloing pressure after recontractive operation of Oral cancer
Scientific Title
An observational study to evaluate the relasionship between swalloing function and swalloing pressure in a Patient after recontractive operation of Oral cancer
Scientific Title:Acronym
The study of swalloing pressure after recontractive operation of Oral cancer
Region
| Japan |
Condition
Condition
oral cacer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluation the relationship between
swalloing function and swalloing pressure
after reconstractive operation for oral
cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The relationship between Swalloing function and Swalloing pressure
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
a patient after oral canser surgery with
reconstraction
Key exclusion criteria
patents judged inappropriate for this study by the physicians
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nibu Ken-ichi |
Organization
Kobe University Graduate School of Medicine
Division name
Department of otorhinolarngology Head and Neck surgery
Zip code
Address
7-5-1,Kusunoki-cho,Chuo-uku,Kobe,Hyougo,650-0017,Japan
TEL
81-78-382-5111
nibu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nibu Ken-ichi |
Organization
Kobe University Graduate School of Medicine
Division name
Department of otorhinolarngology Head and Neck surgery
Zip code
Address
7-5-1,Kusunoki-cho,Chuo-uku,Kobe,Hyougo,650-0017,Japan
TEL
81-78-382-5111
Homepage URL
http://www.hosp.kobe-u.ac.jp/chiken/OOchiken_top.htm
nibu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Department of otorhinolarngology Head and Neck surgery
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine
Department of otorhinolarngology Head and Neck surgery
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
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
| 2017 | Year | 11 | Month | 01 | 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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
the observational study
Management information
Registered date
| 2017 | Year | 10 | Month | 04 | Day |
Last modified on
| 2017 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032649
