UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024523 |
|---|---|
| Receipt number | 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 | 2022/08/12 12:07:53 |
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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 | Kosuke Matsui |
| Middle name | |
| Last name | Kosuke Matsui |
Organization
Kansai Medical University
Division name
Surgery
Zip code
573-1191
Address
2-5-1 Shinmachi, Hirakata, Osaka
TEL
072-801-0101
matsuik@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke Matsui |
| Middle name | |
| Last name | Kosuke Matsui |
Organization
Kansai Medical University
Division name
Surgery
Zip code
573-1191
Address
2-5-1 Shinmachi, Hirakata, Osaka
TEL
072-801-0101
Homepage URL
matsuik@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
Kansai Medical University
Address
Shinmachi Hirakata 20501
Tel
072-801-0101
matsuik@hirakata.kmu.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
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
99
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
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 01 | Day |
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
| 2022 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028220
