UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055895 |
|---|---|
| Receipt number | R000063839 |
| Scientific Title | Efficacy of Perioperative Interferential Current Stimulation in patients after esophageal cancer surgery |
| Date of disclosure of the study information | 2024/12/04 |
| Last modified on | 2024/10/21 11:57:28 |
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Basic information
Public title
Efficacy of Perioperative Interferential Current Stimulation in patients after esophageal cancer surgery
Acronym
Efficacy of Perioperative Interferential Current Stimulation in patients after esophageal cancer surgery
Scientific Title
Efficacy of Perioperative Interferential Current Stimulation in patients after esophageal cancer surgery
Scientific Title:Acronym
Efficacy of Perioperative Interferential Current Stimulation in patients after esophageal cancer surgery
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Postoperative esophageal cancer patients occasionally experience silent aspiration due to dysphagia and reduced cough reflex cervical muscle dissection and lymph node dissection. Although the pathophysiology was not clear, we recently elucidated part of the cause by conducting video-fluoroscopic swallowing and cough tests during the perioperative period. This study aims to evaluate the efficacy of combining an interferential current stimulation with conventional swallowing rehabilitation. This research may establish a new rehabilitation method to improve dysphagia and cough reflex.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effectiveness of swallowing rehabilitation using interferential current stimulation after esophageal cancer surgery
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
| Device,equipment |
Interventions/Control_1
Direct swallowing training is started on the 7th day after esophageal cancer surgery. At the same time, treatment with the interferential current stimulation is started.
The electrode pad of the interferential current stimulation is attached to the patient's neck, and treatment is given using 50 Hz interference current stimulation, twice a day (15 minutes per session) for 5 days a week until discharge.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cervical esophagogastrostomy for esophageal cancer surgery at the Department of Upper Gastroenterological Surgery, Hyogo Medical University.
Key exclusion criteria
(1) A patient with allergies to citric acid, barium, and or gastrografin.
(2) A patient with an implanted electronic medical device, such as a pacemaker or implantable cardioverter-defibrillator (ICD).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Shinohara |
Organization
Hyogo Medical University Hospital
Division name
Department of Gastroenterological Surgery, Division of Upper GI.
Zip code
663-8501
Address
1-1 Mukogawacho, Nishinomiya city, Hyogo
TEL
0798-45-6111
shinohara@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Ishida |
Organization
Hyogo Medical University Hospital
Division name
Department of Gastroenterological Surgery, Divison of Upper GI.
Zip code
663-8501
Address
1-1 Mukogawacho, Nishinomiya city, Hyogo
TEL
0798-45-6111
Homepage URL
ishida@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hyogo Medical University Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Hyogo Medical University
Address
1-1 Mukogawacho, Nishinomiya city, Hyogo
Tel
0798-45-6111
rinri@hyo-med.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 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063839
