UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037097 |
|---|---|
| Receipt number | R000042263 |
| Scientific Title | Analysis about the effect of voice therapy for vocal fold paralysis after esophagectomy |
| Date of disclosure of the study information | 2019/06/18 |
| Last modified on | 2019/06/18 10:07:41 |
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Basic information
Public title
Analysis about the effect of voice therapy for vocal fold paralysis after esophagectomy
Acronym
vocal fold paralysis and voice therapy
Scientific Title
Analysis about the effect of voice therapy for vocal fold paralysis after esophagectomy
Scientific Title:Acronym
vocal fold paralysis and voice therapy
Region
| Japan |
Condition
Condition
Vocal fold paralysis
Classification by specialty
| Gastrointestinal surgery | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effectiveness of voice therapy for the patients who had the unilateral vocal fold paralysis after esophagectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The recovery of postoperative vocal fold paralysis and vocal function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
voice therapy group
Interventions/Control_2
control group
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The cases that prevented the recurrent nerve after esophagectomy
Key exclusion criteria
1.the cases that general condition became worse after surgery
2.the cases that lymph nodes recurrence of areas around recurrent nerve
3.possibility of lack of examination security
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Miyata |
Organization
Kansai Medical University
Division name
Department of Otolaryngology Head & Neck surgery
Zip code
573-1191
Address
2-5-1 Shinmachi, Hirakata, Osaka
TEL
072-804-0101
eri07251014@gmail.com
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Miyata |
Organization
Kansai Medical University
Division name
Department of Otolaryngology Head & Neck surgery
Zip code
573-1191
Address
2-5-1 Shinmachi, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
eri07251014@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
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
Kansai Medical University
Address
2-5-1 Shinmachi, Hirakata, Osaka
Tel
072-804-0101
eri07251014@gmail.com
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
| 2019 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
I am currently writing a article describing the protocol.
Publication of results
Unpublished
Result
URL related to results and publications
I am currently writing a article describing the protocol.
Number of participants that the trial has enrolled
60
Results
We considered that voice therapy improved the vocal function.
Results date posted
| 2019 | Year | 06 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1.Voice therapy group
Male 5, Female 1
Average age 70.8
2.Control group
Male 10. Female 1
Average age 66.4
Participant flow
Twenty patients were randomly assigned to voice therapy or no treatment group.
Adverse events
None
Outcome measures
1.Aerodynamic test
2.Laryngeal endoscopy
3.Pulmonary function test
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2017 | 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
| 2019 | Year | 06 | Month | 18 | Day |
Last modified on
| 2019 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042263
