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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036014
Receipt No. R000041025
Scientific Title A new technique for glans reconstruction after phalloplasty
Date of disclosure of the study information 2019/03/03
Last modified on 2019/03/02

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Basic information
Public title A new technique for glans reconstruction after phalloplasty
Acronym A new technique for glans reconstruction after phalloplasty
Scientific Title A new technique for glans reconstruction after phalloplasty
Scientific Title:Acronym A new technique for glans reconstruction after phalloplasty
Region
Asia(except Japan)

Condition
Condition we needed to new surgical technique for glans reconstruction in transsexual patients
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 durability and patients satisfaction about surgical resaults
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes durability of glans shape after 6and 12 months postoperation
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 we compared the results of old and new technique:
control:norfolk technique as a routine tevhnique
case:our new technique
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
18 years-old <=
Age-upper limit
60 years-old >=
Gender Female
Key inclusion criteria transsexual
Key exclusion criteria smokers,diabetics
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name dr.saboury
Organization St.fatima plastic surgey center
Division name plastic surgery
Zip code
Address 23 rd,yousefabad,Tehran,Iran
TEL 00982188265535
Email dr.mahdysaboury@yahoo.com

Public contact
Name of contact person
1st name
Middle name
Last name mahdy saboury
Organization St.fatima plastic surgey center
Division name plastic surgery
Zip code
Address 21/1 ebnesina ave,Tehran,Iran
TEL 00989021120064
Homepage URL
Email dr.mahdysaboury@yahoo.com

Sponsor
Institute St.fatima plastic SURGERYcenter
Iran university of medical sciences
Institute
Department

Funding Source
Organization St.fatima plastic surgery center

Iran university of medical sciences
Organization
Division
Category of Funding Organization Outside Japan
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
2019 Year 03 Month 03 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 Open public recruiting
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 02 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
2019 Year 02 Month 26 Day
Last modified on
2019 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041025

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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