UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040760 |
|---|---|
| Receipt number | R000046544 |
| Scientific Title | Factors associated with persistent dyspnea in patients undergoing surgery on the esophagus |
| Date of disclosure of the study information | 2020/06/14 |
| Last modified on | 2024/06/17 10:07:44 |
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Basic information
Public title
Factors associated with persistent dyspnea in patients undergoing surgery on the esophagus
Acronym
Factors associated with persistent dyspnea in patients undergoing surgery on the esophagus
Scientific Title
Factors associated with persistent dyspnea in patients undergoing surgery on the esophagus
Scientific Title:Acronym
Factors associated with persistent dyspnea in patients undergoing surgery on the esophagus
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the factors associated with persistent dyspnea in patients undergoing surgery on the esophagus
Basic objectives2
Others
Basic objectives -Others
Determining the prevalence of dyspnea in patients undergoing surgery on the esophagus
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dyspnea
Key secondary outcomes
inspiratory muscle, quadriceps force, two minutes walk distance
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who received rehabilitation requests before surgery
2.Patients who can be evaluated and exercise
Key exclusion criteria
1.Patients with severe central nervous system and motor disorders and cognitive impairment
2.Patients with severe hearing or visual impairment
3.Patients who cannot understand the purpose of the research and have difficulty communicating
4.Patients who cannot obtain the examination permission from their doctor due to postoperative complications
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Nagura |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
TEL
0958197258
nagura@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Nagura |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
TEL
0958197258
Homepage URL
nagura@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Drpartment of Physical Therapy Science, Nagasaki University Graduate School of Biomedical Sciences
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
Tel
0958197200
gaibushikin@ml.nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2020 | Year | 06 | Month | 14 | Day |
Last modified on
| 2024 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046544
