UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000037097 |
| Receipt No. | 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 (Ver. 1) |
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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 |
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| Condition | |||
| Condition | Vocal fold paralysis | ||
| Classification by specialty |
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| 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 |
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| 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 |
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| Age-upper limit |
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| 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 |
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| Target sample size | 100 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 |
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| 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 | |
| Institute | Kansai Medical University |
| Institute | |
| Department | |
| 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 |
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| 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. |
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| Results date posted |
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| 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 |
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| Participant flow | Twenty patients were randomly assigned to voice therapy or no treatment group. |
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| Adverse events | None |
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| Outcome measures | 1.Aerodynamic test 2.Laryngeal endoscopy 3.Pulmonary function test |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042263 |
