UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036189 |
|---|---|
| Receipt number | R000041182 |
| Scientific Title | Examination of Factors Affecting Swallowing Function in Patients Following Resection for Head and Neck Tumor |
| Date of disclosure of the study information | 2019/03/14 |
| Last modified on | 2022/03/16 10:51:44 |
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Basic information
Public title
Examination of Factors Affecting Swallowing Function in Patients Following Resection for Head and Neck Tumor
Acronym
Swallowing Function in Patients Following Resection for Head and Neck Tumor
Scientific Title
Examination of Factors Affecting Swallowing Function in Patients Following Resection for Head and Neck Tumor
Scientific Title:Acronym
Swallowing Function in Patients Following Resection for Head and Neck Tumor
Region
| Japan |
Condition
Condition
Head and Neck Tumor
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between surgical resecti on and swallowing dysfunction by evaluating swal lowing function before and after surgery for patien ts scheduled to undergo head and neck tumor surg ery.
To clarify the relationship between the videofluoro scopic swallowing study (VFSS) result and the sw allowing screening test result for patients who und erwent VFSS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The score of swallowing screening tests
Key secondary outcomes
The score of penetration-aspiration(PA) scale
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Scheduled for surgical resection of head and neck tumor.
Key exclusion criteria
1) Having severe dementia or higher cerebral dysfunction with a preoperative revised Hasegawa's dementia scale under 20 points.
2) Discontinuing the study due to relocation or other reasons.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Kishimoto |
Organization
Hyogo College of Medicine
Division name
Depertment of Dentistry and Oral & Maxillofacial Surgery
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6677
kisihiro@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Hasegawa |
Organization
Hyogo College of Medicine
Division name
Depertment of Dentistry and Oral & Maxillofacial Surgery
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6677
Homepage URL
cem17150@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of Medicine Institutional Review Board
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
Tel
0798456066
rinri@hyo-med.ac.jp
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
| 2019 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
182
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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe the time-course changes of the dysphagia screening test results in head and neck tumor patients by evaluating the perioperative swallowing function.
Management information
Registered date
| 2019 | Year | 03 | Month | 13 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041182
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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