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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038361
Receipt No. R000043718
Scientific Title Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients
Date of disclosure of the study information 2020/04/01
Last modified on 2021/05/24

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Basic information
Public title Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients
Acronym Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients
Scientific Title Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients
Scientific Title:Acronym Study on the relationship between gum chewing during perioperative period and tangue pressure in esophageal cancer patients
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastrointestinal surgery Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between gum chewing training during perioperative period and tongue pressure after surgery in the patients with esophageal cancer surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The ratio of the patients whose tongue pressure was decreased the day after 2 weeks of surgery
Key secondary outcomes The following data will be evaluated on 1) The starting day of gum chewing, 2) The day before surgery, 3) The day after 2 weeks of surgery.
-Swallowing function: tongue pressure, RSST, presence/absence of recurrent laryngeal nerve palsy, oral diadocokinesis
-Masticatory function: Masticatory ability, occlusal force
-Oral hygiene: degree of tongue coating, total number of bacteria on back of tongue, bacterial flora
-Mouth dryness: Oral moisture meter measurement value
-Equilibrium function: Opening one leg up time

The following data will be evaluated on the period between the starting day of gum chewing and the day of end of observational period
-Adverse events, safety: Postoperative complications such as suture failure, accidents due to gum mastication (detachment of prostheses and restorations, temporomandibular joint pain, etc.), and other adverse events
-Postoperative lung complications (JCOG postoperative complication criteria (Clavien-Dindo classification)) v2.0
-Nutrition related items: Oral intake start time, discharge time, ratio of oral intake to total nutrition intake, ratio of home discharge and hospital transfer, etc.
-Postoperative delirium: Contents of medical records

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food
Interventions/Control_1 Gum chewing training during perioperative period in the patients with esophageal cancer
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
80 years-old >
Gender Male and Female
Key inclusion criteria The patients who undergo thoracic esophageal cancer surgery at our hospital
1) The patients who will undergo primary radical operation
2) The Patients who have received sufficient explanation for participation in this study, and who have received sufficient written consent from the patient himself / herself with sufficient understanding
Key exclusion criteria 1)The patients who cannot gum chewing because of denture or something
2) The Patients who are determined to be inappropriate as research subjects by the principal investigator or other investigators

Target sample size 40

Research contact person
Name of lead principal investigator
1st name Reiko
Middle name Yamanaka
Last name Kohno
Organization Okayama University Hospital
Division name Hospital Dentistry
Zip code 7008558
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 81862356588
Email reiko_y@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name Reiko
Middle name Yamanaka
Last name Kohno
Organization Okayama University hospital
Division name Hospital Dentistry
Zip code 7008558
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 81862356588
Homepage URL
Email reiko_y@md.okayama-u.ac.jp

Sponsor
Institute Hospital Dentistry, Okayama University Hospital
Institute
Department

Funding Source
Organization the Japan Society for the Promotion of Science (JSPS)
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 Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1, Shikata-cho, kita-ku, Okayama, 7008558
Tel 086-235-6503, 6938
Email mae6605@adm.okayama-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 岡山大学病院

Other administrative information
Date of disclosure of the study information
2020 Year 04 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 Open public recruiting
Date of protocol fixation
2019 Year 10 Month 23 Day
Date of IRB
2020 Year 09 Month 29 Day
Anticipated trial start date
2021 Year 03 Month 29 Day
Last follow-up date
2023 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
2019 Year 10 Month 22 Day
Last modified on
2021 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043718

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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