UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050815 |
|---|---|
| Receipt number | R000057877 |
| Scientific Title | Comprehensive investigation of dysphagia and consideration of the compensatory posture after surgery for thoracic esophageal cancer |
| Date of disclosure of the study information | 2024/02/15 |
| Last modified on | 2025/04/14 17:39:29 |
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Basic information
Public title
Comprehensive investigation of dysphagia and consideration of the compensatory posture after surgery for thoracic esophageal cancer
Acronym
Comprehensive investigation of dysphagia and consideration of the compensatory posture after surgery for thoracic esophageal cancer
Scientific Title
Comprehensive investigation of dysphagia and consideration of the compensatory posture after surgery for thoracic esophageal cancer
Scientific Title:Acronym
Comprehensive investigation of dysphagia and consideration of the compensatory posture after surgery for thoracic esophageal cancer
Region
| Japan |
Condition
Condition
thoracic esophageal cancer
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate dysphagia after surgery for thoracic esophageal cancer comprehensively.
To clarify the outcome of swallowing ability and the effect of neck rotation during swallowing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Swallowing ability at discharge
Modified water swallowing test
Eating assessment tool-10
Key secondary outcomes
Effect of neck rotation during swallowing
Penetration aspiration scale
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
| Maneuver |
Interventions/Control_1
To examine the effects of neck rotation during swallowing using video-fluoroscopy
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing thoracoscopic or mediastinoscopic esophagectomy at Department of Gastroenterological Surgery at our hospital due to thoracic esophageal cancer
Patients who received sufficient explanations for participation in this study and obtained written consent of the patients' own free will
Key exclusion criteria
Patients to whom rehabilitation were not performed due to poor general condition.
Patients who were judged to be inappropriate for this study due to many comorbidities by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Eiko |
| Middle name | |
| Last name | Sunami |
Organization
Nippon medical school
Division name
Department of rehabilitation medicine
Zip code
113-8603
Address
1-1-5,Sendagi,Bunkyo-ku,Tokyo
TEL
0338222131
s2047@nms.ac.jp
Public contact
Name of contact person
| 1st name | Eiko |
| Middle name | |
| Last name | Sunami |
Organization
Nippon medical school
Division name
Department of rehabilitation medicine
Zip code
113-8603
Address
1-1-5,Sendagi,Bunkyo-ku,Tokyo
TEL
0338222131
Homepage URL
s2047@nms.ac.jp
Sponsor or person
Institute
Nippon medical school
Institute
Department
Personal name
Funding Source
Organization
Nippon medical school
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
Central ethics committee of Nippon medical school
Address
1-1-5,Sendagi,Bunkyo-ku,Tokyo
Tel
0338222131
chuorinri.group@nms.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
| 2024 | Year | 02 | Month | 15 | 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
| 2022 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057877
