UMIN-CTR Clinical Trial

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
Email	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
Email	sakiko@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051278