UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pitch elevation surgery for gender identity patients
Title of the study (Brief title)	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	YuzabroNanba
Organization	Okayama university hospital
Division name	Gender center
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	YukoKatayama
Organization	Okayama university hospital
Division name	Plastic surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016405