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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022689
Receipt No. R000026154
Scientific Title Examination of the lymphedema improvement with the surgical combination therapy for secondary limbs lymphedema
Date of disclosure of the study information 2016/06/30
Last modified on 2016/06/10

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Basic information
Public title Examination of the lymphedema improvement with the surgical combination therapy for secondary limbs lymphedema
Acronym Examination of the lymphedema improvement with the surgical combination therapy
Scientific Title Examination of the lymphedema improvement with the surgical combination therapy for secondary limbs lymphedema
Scientific Title:Acronym Examination of the lymphedema improvement with the surgical combination therapy
Region
Japan

Condition
Condition Lymphedema
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We determine improvement with the surgical combination therapy for lymphedema
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Limbs circumference, ICG fluorescent lymphography, SF36
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Vasculized lymph node transfer(VLNT)
Interventions/Control_2 Vasculized lymph node transfer, Lymphaticovenuler anastomosis(LVA)
Interventions/Control_3 Lymphaticovenuler anastomosis
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who there is secondary lymphedema, and expect surgical cure.
The person who is available for LVA conducts LVA by ICG lymphangiography. The person with the LVA treatment resistance receives LNT or VLNT+LVA.
Key exclusion criteria Those whom we considre inappropiate due to physical and/or mental problem
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukiko Kuramoto
Organization Cancer Institute Hospital
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address 3-8-31 Ariake, Koutou-ku, Tokyo, 135-8550 Japan
TEL 03-3520-0111
Email yukiko.kuramoto@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukiko Kuramoto
Organization Cancer Institute Hospital
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address 3-8-31 Ariake, Koutou-ku, Tokyo, 135-8550 Japan
TEL 03-3520-0111
Homepage URL
Email yukiko.kuramoto@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital
Institute
Department

Funding Source
Organization Cancer Institute Hospital
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
2016 Year 06 Month 30 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 Preinitiation
Date of protocol fixation
2016 Year 06 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 07 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
2016 Year 06 Month 10 Day
Last modified on
2016 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026154

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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