UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055581 |
|---|---|
| Receipt number | R000063498 |
| Scientific Title | Examination of comprehensive oral care intervention methods for preventing postoperative infectious complications in patients undergoing head and neck cancer surgery and verification of their effectiveness |
| Date of disclosure of the study information | 2024/09/22 |
| Last modified on | 2025/01/18 08:56:42 |
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Basic information
Public title
Research on the prevention of infectious complications due to oral care following head and neck tumor resection
Acronym
Research on the prevention of infectious complications due to oral care following head and neck tumor resection
Scientific Title
Examination of comprehensive oral care intervention methods for preventing postoperative infectious complications in patients undergoing head and neck cancer surgery and verification of their effectiveness
Scientific Title:Acronym
Examination of comprehensive oral care intervention methods for preventing postoperative infectious complications in patients undergoing head and neck cancer surgery
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Conduct comprehensive oral care interventions that combine 1) oral moisturization, 2) oral self-care guidance, and 3) oral observation and oral care for head and neck cancer patients, and clarify its preventive effect of postoperative infectious complications, oral hygiene status, self-efficacy regarding oral self-care, and effect on oral-related QOL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Incidence of postoperative infectious complications (pneumonia, SSI)
Key secondary outcomes
Self-efficacy for oral self-care, oral hygiene status, oral-related QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
(1) Oral moisturization using oral moisturizers
(2) Oral self-education according to dry mouth level and disease
(3) Individual oral assessment and oral care by nurses
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with oral cancer, pharyngeal cancer, or laryngeal cancer and who are undergoing surgery
(2) Patients who can independently give consent
(3) Patients at least 18 years of age
Key exclusion criteria
(1) Endoscopic surgery
(2) Surgery for lymphadenectomy only, without tumor removal
(3) Partial tongue resection
(4) Patients judged as inappropriate for clinical practice by researcher or physician
(5) Patients with milk allergies
(6) Patients who have not undergone perioperative oral care interventions
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Kimie |
| Middle name | |
| Last name | Fujita |
Organization
Kyushu University
Division name
Nursing Couse Department of Health Sciences Faculty of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6738
fujita.kimie.874@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Mina |
| Middle name | |
| Last name | Matsumura |
Organization
Kyushu University
Division name
Department of Health Sciences, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6738
Homepage URL
matsumura.mina.466@s.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Mina Matsumura
Funding Source
Organization
JSPS KAKENHI
Japan Academy of Nursing Sciences
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical and Translational Research (CCTR) of Kyushu University Hospital
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5774
tr-info@med.kyushu-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
九州大学病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063498
