UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044899 |
|---|---|
| Receipt number | R000051278 |
| Scientific Title | A prospective observational study of the effects of swallowing function, feeding status, and gargling on salivary bacterial counts in patients undergoing oral cancer surgery |
| Date of disclosure of the study information | 2021/07/21 |
| Last modified on | 2022/07/20 17:18:23 |
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Basic information
Public title
A prospective observational study of the effects of swallowing function, feeding status, and gargling on salivary bacterial counts in patients undergoing oral cancer surgery
Acronym
Relationship between swallowing function, feeding status, gargling and salivary bacterial count in patients undergoing oral cancer surgery
Scientific Title
A prospective observational study of the effects of swallowing function, feeding status, and gargling on salivary bacterial counts in patients undergoing oral cancer surgery
Scientific Title:Acronym
Relationship between swallowing function, feeding status, gargling and salivary bacterial count in patients undergoing oral cancer surgery
Region
| Japan |
Condition
Condition
Oral cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the risk factors for the increase in the number of bacteria by measuring the number of bacteria in saliva before and after oral cancer surgery
Basic objectives2
Others
Basic objectives -Others
The change of number of bacterial count before and after surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of bacteria in saliva, presence or absence of swallowing dysfunction and feeding status, before and after surgery
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
Patients who undergo oral cancer surgery under general anesthesia at Nagasaki University Hospital from the date of permission from the hospital director to July 31, 2022 (including recurrence).
Key exclusion criteria
1.Patients managed under intubation after surgery (oral or nasal intubation, tracheostomy)
2.Patients without wounds in the oral cavity ( only Neck dissection surgery)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University Graduate School of
Biomedical Sciences
Division name
Department of Oral Health
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7698
sakiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Oral Health
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-8197-698
Homepage URL
sakiko@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
The Institutional Review Board (IRB) of Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.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
| 2021 | Year | 07 | 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
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
| 2021 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurement of the number of bacteria in saliva
Management information
Registered date
| 2021 | Year | 07 | Month | 19 | Day |
Last modified on
| 2022 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051278
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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