UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030572 |
|---|---|
| Receipt number | R000034904 |
| Scientific Title | Effect of prehospital oral care on prevention of postoperative aspiration pneumonia in cancer patients. |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2024/07/01 11:13:56 |
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Basic information
Public title
Effect of prehospital oral care on prevention of postoperative aspiration pneumonia in cancer patients.
Acronym
Effect of prehospital oral care on prevention of postoperative aspiration pneumonia in cancer patients.
Scientific Title
Effect of prehospital oral care on prevention of postoperative aspiration pneumonia in cancer patients.
Scientific Title:Acronym
Effect of prehospital oral care on prevention of postoperative aspiration pneumonia in cancer patients.
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of prehospital oral care in prevention of postoperative pneumonia associated with cancer surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of postoperative pneumonia
Key secondary outcomes
ORAL HEALTH ASSESSMENT TOOL
Activities of dayly living(Barthel index, FIM)
Nutriation status
Postoperative side effects
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
･Cancer patients who were underwent the surgery
Key exclusion criteria
Patients who deny the enrollment of this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Enishi |
Organization
Tokushima Municipal Hospital
Division name
Rehabilitation Medicine
Zip code
7700812
Address
2-34, Kitajosanjima, Tokushima, Tokushima
TEL
088-622-5121
tetsuya-e@umin.org
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Enishi |
Organization
Tokushima Municipal Hospital
Division name
Rehabilitation Medicine
Zip code
7700812
Address
2-34, Kitajosanjima, Tokushima, Tokushima
TEL
088-622-5121
Homepage URL
tetsuya-e@umin.org
Sponsor or person
Institute
Tokushima Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima municipal hospital
Address
2-34, Kitajousanjima, Tokushima, Tokushima
Tel
0886225121
tetsuya-e@umin.org
Secondary IDs
Secondary IDs
YES
Study ID_1
2017-12
Org. issuing International ID_1
Tokushima Municipal Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
徳島市民病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 01 | Day |
Other
Other related information
not yet started
Management information
Registered date
| 2017 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034904
