UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016701 |
|---|---|
| Receipt number | R000018759 |
| Scientific Title | To validate the efficiency of patient-centered noninvasive conservative treatment of vocal cord polyp and/or vocal nodule achieved by vocal hygiene education. |
| Date of disclosure of the study information | 2015/03/06 |
| Last modified on | 2022/12/13 10:57:04 |
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Basic information
Public title
To validate the efficiency of patient-centered noninvasive conservative treatment of vocal cord polyp and/or vocal nodule achieved by vocal hygiene education.
Acronym
NHO - Reaserach for Vocal Hygiene Education
Scientific Title
To validate the efficiency of patient-centered noninvasive conservative treatment of vocal cord polyp and/or vocal nodule achieved by vocal hygiene education.
Scientific Title:Acronym
NHO - Reaserach for Vocal Hygiene Education
Region
| Japan |
Condition
Condition
Vocalcord polyp, vocal nodule
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the efficiency of patient-centered noninvasive conservative treatment of vocal cord polyp and/or vocal nodule achieved by vocal hygiene education through examining nonintervention groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Examining the amount of regression seen in a patient's condition (vocal cord polyp/vocal nodule), after 2 months of outpatient service.
Key secondary outcomes
Change in condition (the presence or absence of glottal/ membrane fluctuation), objective voice evaluation (GRBAS, phonetic function test, MPT), change in patients subjective satisfaction (VHI), adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In consideration of the vocal hygiene educational program, the speech therapist or main physician should advise the patient in accordance with their lifestyle.
Decide the indication of the surgery after
6 months.
Interventions/Control_2
Patients are not introduced to the vocal hygiene educational program, and are not advised to change their lifestyle.
Decide the indication of the surgery after
6 months.
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 have been diagnosed with vocal cord polyp or vocal nodule through the use of fiberscopy/ stroboscopy.
2. Patients who have been indicated for phonosurgery due to hoarseness.
3. Patients able to wait at least 2 months before surgery.
4. Male and Female over 20 years of age.
5. Patients who have agreed to join the resaerch and willingly signed a medical ethics application form.
Key exclusion criteria
1. Laryngeal examination (fiberscopic and/or stroboscopic study, etc.) suggests laryngeal cancer.
2. Laryngeal examination (fiberscopic and/or stroboscopic study, etc.) suggests laryngeal granuloma.
3. Laryngeal examination (fiberscopic and/or stroboscopic study, etc.) suggests tuberculosis.
4. Laryngeal examination (fiberscopic and/or stroboscopic study, etc.) suggests collagen disease.
5. Laryngeal examination (fiberscopic and/or stroboscopic study, etc.) suggests laryngeal cyst.
6. Laryngeal examination (fiberscopic and/or stroboscopic study, etc.) suggests Reinke's edema.
7. Patients who need surgery within 2 months.
8. Patients denied participation by their physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Tsunoda |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Artificial Organs and Medical Creations
Zip code
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
tsunodakoichi@kankakuki.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Tsunoda |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Artificial Organs and Medical Creations
Zip code
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
Homepage URL
http://www.kankakuki.go.jp/lab_d.html
onseishitsumon@kankakuki.go.jp
Sponsor or person
Institute
National Hospital Organization Japan
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
NHO東京医療センター
NHO千葉医療センター
NHO仙台医療センター
NHO相模原病院
NHO神戸医療センター
NHO名古屋医療センター
NHO長崎医療センター
NHO三重病院
NHO水戸医療センター
NHO金沢医療センター
NHO栃木医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
https://doi.org/10.1002/lary.27415
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1002/lary.27415
Number of participants that the trial has enrolled
200
Results
Hosoya M, Kobayashi R, Ishii T, Senarita M, Kuroda H, Misawa H, Tanaka F, Takiguchi T, Tashiro M, Masuda S, Hashimoto S, Goto F, Minami S, Yamamoto N, Nagai R, Sayama A, Wakabayashi T, Toshikuni K, Ueha R, Fujimaki Y, Takazawa M, Sekimoto S, Itoh K, Nito T, Kada A, Tsunoda K. Vocal Hygiene Education Program Reduces Surgical Interventions for Benign Vocal Fold Lesions: A Randomized Controlled Trial. Laryngoscope. 2018 Nov;128(11):2593-2599. doi: 10.1002/lary.27415.
Results date posted
| 2022 | Year | 12 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
n=200
Participant flow
Multicenter Randomized Control Trial
Adverse events
None
Outcome measures
Two months after enrollment, the patients in both groups underwent laryngeal fiberscopic examinations to determine whether the benign lesions had resolved or whether surgery was indicated for the vocal fold polyps/nodules.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 06 | 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
| 2015 | Year | 03 | Month | 04 | Day |
Last modified on
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018759
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/09/04 | KTR【final protocol】NHO Koichi Tsunoda English ver.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
