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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028872
Receipt No. R000033042
Scientific Title Effect of continuous oral care after surgery on the general condition in perioperative patients
Date of disclosure of the study information 2017/08/29
Last modified on 2017/08/29

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Basic information
Public title Effect of continuous oral care after surgery on the general condition in perioperative patients
Acronym Oral care and general condition in perioperative patients
Scientific Title Effect of continuous oral care after surgery on the general condition in perioperative patients
Scientific Title:Acronym Oral care and general condition in perioperative patients
Region
Japan

Condition
Condition Lung and esophagus cancer
Classification by specialty
Gastrointestinal surgery Chest surgery Dental medicine
Nursing Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 How continuous dental intervention after surgery can contribute to recovery of general condition in patients with perioperative period.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Days of postoperative fever-up
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Group performing continuous postoperative oral care
Interventions/Control_2 Group performing normal oral care after surgery
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with lung or esophageal cancer surgery in Okayama University Hospital Perioperative Management Center
Key exclusion criteria Patient who can't obtain informed consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Morita
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Preventive Dentistry
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-6712
Email mmorita@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Morita
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Preventive Dentistry
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-6712
Homepage URL
Email mmorita@md.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Minstry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 08 Month 29 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
2012 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 29 Day
Last modified on
2017 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033042

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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