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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024523
Receipt No. R000028220
Scientific Title Examination of perioperative swallowing dysfunction for the elderly patients
Date of disclosure of the study information 2016/11/01
Last modified on 2016/10/21

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Basic information
Public title Examination of perioperative swallowing dysfunction for the elderly patients
Acronym Examination of perioperative swallowing dysfunction for the elderly patients
Scientific Title Examination of perioperative swallowing dysfunction for the elderly patients
Scientific Title:Acronym Examination of perioperative swallowing dysfunction for the elderly patients
Region
Japan

Condition
Condition hepatectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To identify the factors that decreased swallowing function after hepatectomy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes RSS, MWST
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 To evaluate the swallowing function in the perioperative period
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients age is older than or equal to 70 years old
2. Patients before hepatectomy
3. Patients obtained document consent
Key exclusion criteria 1. Uncontrolled infections
2. Severe mental disorder
3. Emergency surgery
4. Inappropriate patients
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kosuke Matsui
Organization Kansai Medical University
Division name Surgery
Zip code
Address 2-5-1 Shinmachi, Hirakata, Osaka
TEL 072-801-0101
Email matsuik@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kosuke Matsui
Organization Kansai Medical University
Division name Surgery
Zip code
Address 2-5-1 Shinmachi, Hirakata, Osaka
TEL 072-801-0101
Homepage URL
Email matsuik@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization N/A
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
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
2016 Year 11 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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 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
2016 Year 10 Month 21 Day
Last modified on
2016 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028220

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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