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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031462
Receipt No. R000035913
Scientific Title Lymphatic Venous Anastomosis for secondary lymphedema -Randamized Control Trial-
Date of disclosure of the study information 2018/02/24
Last modified on 2018/03/01

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Basic information
Public title Lymphatic Venous Anastomosis for secondary lymphedema -Randamized Control Trial-
Acronym LVA for secondary lymphedema
Scientific Title Lymphatic Venous Anastomosis for secondary lymphedema -Randamized Control Trial-
Scientific Title:Acronym LVA for secondary lymphedema
Region
Japan

Condition
Condition Secondary lymphedema
Classification by specialty
Surgery in general Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is a randomized controlled trial of LVA and nonsurgical therapy.
We evaluate and compare lymphoedema improvement and deterioration by randomly assigning LVA and nonsurgical therapy to patients who visited JR Tokyo General Hospital lymphatic surgery / reconstructive surgery and observing for 6 months.
Currently, the effect of LVA on lymphoedema has been reported, and it can be fully expected that this clinical effect can be obtained by this research.

This study will contribute to the development of a more effective treatment method compared with the compound physiotherapy which is currently regarded as standard treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluate based on the change in the number of times of cellulitis. In the LVA group, the number of times of cellulitis inflammation during 24 weeks before the start of the intervention and 24 weeks after the start of the intervention is compared. In the conservative therapy group, we compare the number of times of cellulitis in 24 weeks before the allocation date and 24 weeks after the allocation date. Huigong weeping inflammation is defined as having inflammatory findings such as redness and heat sensation on the affected limb and having a fever of 38.5 degrees or more.
Key secondary outcomes 1.circumference of affected limb
Measure with six tapes of 20 cm above the knee, 10 cm above the knee, knee joint, 10 cm below the knee, ankle joint and foot sole, and calculate the rate of change based on the following formula. Measurement is blinded by doing a nurse or a physical therapist who is not involved in surgery and research protocol creation.
Change rate (%) = (Sum of surrounding diameters after operation - Sum of surrounding diameters before surgery) / Sum of peripheral diameter before surgery x 100

2.Pain, discomfort (subjective symptoms)
Record using visual analogue scale (VAS).

3.Subcutaneous tissue hardness
Three types of urethane sponge with different hardness (Yawata Tayzen Co., Ltd.) are used to compare this with the firmness of the skin and subcutaneous tissue of the affected limb by palpation. Evaluate the distal inner and outer side of the lower leg, proximal inner and outer sides of the lower limb, distal inner and outer sides of the thigh, inner side of the thigh and inner side and outer side of the thigh. Each sponge is numbered 2, 4, 6 according to the hardness, 2 points if it is the same hardness as 2, 1 point if it is softer than 2, 3 points if it is hardness between 2 and 4 Evaluate in seven stages of 1 to 7 points. This evaluation is blinded by doing a nurse or a physical therapist who is not involved in surgery and research protocol creation.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 As a surgical treatment, removal of subcutaneous tissues in which elephant-like degenerated skin and fibrosis have progressed, liposuction and the like have been carried out, but JR Tokyo General Hospital lymphatic surgery / reconstructive surgery uses supermicrosurgery technology We are actively doing lymph venous anastomosis (LVA). Internationally, vascular lymph node transplantation is performed more frequently, which seems to be mainly due to the easiness of surgical technique for transplantation with vascular lymph nodes. On the other hand, with vascular lymph node transplantation, there is a possibility that new lymphedema may occur in the lymph node harvesting section after surgery, and case reports are already being conducted at academic conferences, papers and the like.
Our LVA is a minimally invasive surgery which can be performed under local anesthesia and there is no risk of lymphoedema occurring at other sites after surgery, but it is mainly surgery developed in Japan, Currently there is little medical evidence. Internationally, randomized controlled trials on LVA have not been conducted.
Interventions/Control_2 Non-surgical treatment, complex physical therapy
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 1) Patients who received JR Tokyo General Hospital lymphatic surgery / reconstructive surgery
2) Patients diagnosed with secondary lower extremity lymphedema by lymphoscintigraphy
3) Patients who have conservative therapy for more than 3 months already
4) Patients judged to have the ability to answer inquiries
5) Patients who obtained written consent from the patients themselves freely with sufficient understanding after receiving sufficient explanation for participation in this study.
6) In the case that the patient is a minor, 5) In addition to the case that the patient guardian fully understands and obtains written consent.
Key exclusion criteria Patients who conflict with the following criteria shall not be included in this study.
1) Patients who can be expected to have a postoperative follow-up period of less than 6 months at JR Tokyo General Hospital, Bethel Minami Shinjuku Clinic, Medical Corporation Mihara Internal Medicine
2) Patients with complication of edema due to heart failure, renal failure, etc.
3) Cases judged inappropriate by the doctor sharing test
Target sample size 120

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
BETHEL MINAMI-Shinjuku clinic
Mihara Interanal 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 02 Month 24 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

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=R000035913

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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