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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014090
Receipt No. R000016405
Scientific Title Pitch elevation surgery for gender identity patients
Date of disclosure of the study information 2014/08/01
Last modified on 2018/12/13

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Basic information
Public title Pitch elevation surgery for gender identity patients
Acronym Pitch elevation surgery for gender identity patients
Scientific Title Pitch elevation surgery for gender identity patients
Scientific Title:Acronym Pitch elevation surgery for gender identity patients
Region
Japan

Condition
Condition Gender identity disorder
Classification by specialty
Obsterics and gynecology Oto-rhino-laryngology Urology
Plastic surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate efficancy and safety of the new method operation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes evaluate the quality of voice for
Male-to-Female Transsexuals after new method operation
Key secondary outcomes evaluate the degree of satisfaction for
Male-to-Female Transsexuals after new method operation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 patient undergo the operation of pitch elevation surgery for Male-to-Female Transsexuals.
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

Not applicable
Gender Male
Key inclusion criteria 1.Male to Female Transsexuals
2.Adult
3.Speech therapist estimates that patients is not likly to improve his voice sufficiently after voice training.
Key exclusion criteria 1.patient don't give informed consent.
2.patient has psychiatric disorder.
3.patient complain of generalized weakness.
4.patient under age.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name YuzabroNanba
Organization Okayama university hospital
Division name Gender center
Zip code
Address 2-5-1 Shikata-cho Kita-ku Okayama-shi Okayama-ken 700-8558 Japan
TEL 086-235-7214
Email y-nanba@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name YukoKatayama
Organization Okayama university hospital
Division name Plastic surgery
Zip code
Address 2-5-1 Shikata-cho Kita-ku Okayama-shi Okayama-ken 700-8558 Japan
TEL 086-235-7214
Homepage URL
Email okayama-prs@md.okayama-u.ac.jp

Sponsor
Institute Okayama university hospital
department of gender center
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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
2014 Year 08 Month 01 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 Completed
Date of protocol fixation
2014 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 27 Day
Last modified on
2018 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016405

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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