UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042645 |
|---|---|
| Receipt number | R000048641 |
| Scientific Title | The relationship between frailty and postoperative swallowing function - a prospective observational study |
| Date of disclosure of the study information | 2020/12/04 |
| Last modified on | 2023/07/07 09:23:37 |
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Basic information
Public title
The relationship between frailty and postoperative swallowing function - a prospective observational study
Acronym
The relationship between frailty and postoperative swallowing function - a prospective observational study
Scientific Title
The relationship between frailty and postoperative swallowing function - a prospective observational study
Scientific Title:Acronym
The relationship between frailty and postoperative swallowing function - a prospective observational study
Region
| Japan |
Condition
Condition
proximal femoral fracture
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to document the changes in swallowing function before and after surgery in physically frail and non-frail patients and to examine the relationship
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
'Modified Water Swallowing Test' scores before and after surgery in frail patients
Key secondary outcomes
The 'Modified Water Swallowing Test' scores on different anesthesia methods
'Modified Water Swallowing Test' scores before and after surgery in non-frail patients
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are at least 20 years old at the time of obtaining consent
(2) Patients who consented to participate in this study
Key exclusion criteria
(1) Patients who did not obtain consent
(2) Patients for whom preoperative information such as modified water drinking test and presence of flail could not be obtained
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tatsunori |
| Middle name | |
| Last name | Watanabe |
Organization
Uonuma Kikan Hospital
Division name
Department of Anesthesiology
Zip code
949-7302
Address
4132 Urasa, Minami Uonuma City, Niigata Prefecture
TEL
025-777-3200
tatsu-w@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Watanabe |
Organization
Uonuma Kikan Hospital
Division name
Department of Anesthesiology
Zip code
949-7302
Address
4132 Urasa, Minami Uonuma City, Niigata Prefecture
TEL
025-777-3200
Homepage URL
tatsu-w@med.niigata-u.ac.jp
Sponsor or person
Institute
Uonuma Kikan Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Uonuma kikan hospital
Address
4132 Urasa, Minami Uonuma City, Niigata Prefecture
Tel
025-777-3200
yaku-info@ncmi.or.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
| 2020 | Year | 12 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 04 | 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
Identify the effects of surgery and anesthesia in frail patients and compare them to non-frail patients
Management information
Registered date
| 2020 | Year | 12 | Month | 04 | Day |
Last modified on
| 2023 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048641
