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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031463
Receipt No. R000035916
Scientific Title Investigation on pathological and biochemical changes and effects of surgery in patients with lymphedema
Date of disclosure of the study information 2018/03/01
Last modified on 2018/03/01

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Basic information
Public title Investigation on pathological and biochemical changes and effects of surgery in patients with lymphedema
Acronym Histological analysis of lymphedema
Scientific Title Investigation on pathological and biochemical changes and effects of surgery in patients with lymphedema
Scientific Title:Acronym Histological analysis of lymphedema
Region
Japan

Condition
Condition lmphedema
Classification by specialty
Surgery in general Plastic surgery Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 At present, the normal of the confluent lymphatic vessels admitted during surgery is visually observed and clinically evaluated the severity of lymphedema, the extent of fibrosis of subcutaneous tissue, and the relation with surgical effect.
Basic objectives2 Others
Basic objectives -Others To evaluate the residual specimen (lymph vessel, surrounding tissue, interstitial fluid) collected at the time of surgery, analyze the relationship between microstructural changes, biochemical change and clinical symptoms and postoperative course We will try to elucidate the pathology of lymphatic diseases including lymphedema and develop new treatments.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We examine the relationship between the data obtained in normal medical practice and the morphological changes and biochemical change of the residual specimen obtained at the time of surgery.
Only SF-36 is newly acquired for this research, and all other data are only existing information obtained by usual medical examination.
The specimens used for this study are only lymphatic vessels, surrounding tissues, and interstitial fluid that have become extra, usually discarded during surgery or treatment.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria A case of lymphedema who was consulted at JR Tokyo General Hospital lymphatic surgery / reconstructive surgery
Key exclusion criteria none
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Mihara
Organization JR Tokyo General Hospital
Division name Lymphatic and Reconstructive Surgery
Zip code
Address Yoyogi 2-1-3, Shibuya-ku, Tokyo, Japan
TEL 03-3320-2200
Email mihara.plasticsurgery@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiko Hayashi
Organization JR Tokyo General Hospital
Division name Pharmaceutical department
Zip code
Address Yoyogi 2-1-3, Shibuya-ku, Tokyo, Japan
TEL 03-3320-2200
Homepage URL
Email 06share09@jreast.co.jp

Sponsor
Institute JR Tokyo General Hospital, Mihara Internal Medicine Clinic
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 03 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 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 The condition before and after the lymphatic surgery is evaluated by aggregation, VAS, volume alteration by tissue altitude, CT or MRI, lymphatic function evaluation by lymphatic penetration, and the like.

Management information
Registered date
2018 Year 02 Month 24 Day
Last modified on
2018 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035916

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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