UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036014 |
|---|---|
| Receipt number | 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 14:18:19 |
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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
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
dr.mahdysaboury@yahoo.com
Sponsor or person
Institute
St.fatima plastic SURGERYcenter
Iran university of medical sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041025
