UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025137
Receipt number R000028909
Scientific Title Lymphatic Venous Anastomosis for Secondary lymphedema.
Date of disclosure of the study information 2017/01/01
Last modified on 2022/09/24 10:43:39

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Basic information

Public title

Lymphatic Venous Anastomosis for Secondary lymphedema.

Acronym

LVA for Lymphedema

Scientific Title

Lymphatic Venous Anastomosis for Secondary lymphedema.

Scientific Title:Acronym

LVA for Lymphedema

Region

Japan


Condition

Condition

Secondary lymphedema

Classification by specialty

Plastic surgery Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study is a randomized controlled trial of LVA and combined physical therapy.
To evaluate and compare lymphoedema improvement and deterioration by randomly assigning LVA and combined physical therapy to patients who have undergone lymphatic and reconstructive surgery, Saiseikai kawaguchi general hospital for 6 months .

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluate with the change in the number of times of cellulitis. In the LVA group, the number of cellulitis times during 24 weeks before the start of intervention and 24 weeks after the start of the intervention is compared. In the CDP therapy group, we compare the number of times of cellulitis in 24 weeks before the allocation date and 24 weeks after the allocation date. Cellulitis is defined as having inflammatory findings such as redness and heat sensation on the affected limbs and having a fever of 38.5 degrees or more.

Key secondary outcomes

1.Limb Circumference
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. Measurements are blinded by doing a nurse or a physical therapist who is not involved in surgery or research protocol creation.
Change rate (%) = (Sum of surgical diameter after surgery - Sum of surrounding diameters before surgery) / Sum of peripheral diameter before surgery x 100

2.Pain and Discomfort
Visual Analogue Scale (VAS) are used

3.Tissue Hardness
Three kinds of urethane sponge with different hardness (Yawataneji K. K., Japan) are used, and the hardness of the skin and subcutaneous tissues of the affected limb is compared by palpation. Evaluate the distal inner and outer side of the lower leg, proximal inner and outer side of the lower thigh, inner side outer side of the thigh, inner side of the thigh and inner side and outer side of the thigh separately. Each sponge is numbered 2, 4, 6 according to the hardness, 2 points if it has 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 and so on. This evaluation is blinded by doing a nurse or a physical therapist who is not involved in surgery and research protocol.

4.QOL
Using SF 36, we perform QOL evaluation before intervention and 6 months after intervention.


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

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Lymphatic Venous Anastomosis

Interventions/Control_2

Complex Decongestive Physiotherapy

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) Saitama kenjinkai Kawaguchi General Hospital Patients who received lymphatic surgery / reconstructive surgery
2) Patients diagnosed with secondary lower extremity lymphoedema by lymphoscintigraphy
3) Patients judged to have the ability to answer interrogation
4) Patients who obtained document consent by the patients themselves freely with sufficient understanding after receiving sufficient explanation for participation in this study.
5) In cases where the patient is a minor, 4) In addition to the patient caregiver sufficient understanding, document consent is obtained.

Key exclusion criteria

Exclusion criteria
Patients who conflict with the following criteria shall not be included in this study.
1) Patients with postoperative observation period of less than 6 months
2) Patients with complication of edema due to heart failure / renal failure etc.
3) Cases judged inappropriate by test doctor

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Mihara

Organization

Saiseikai Kawaguchi General Hospital

Division name

Lymphatic and Reconstructive Surgery

Zip code

332-8558332-8558

Address

5-11-5 Nishikawaguchi, Kawaguchi-shi, Saitama, Japan

TEL

048-253-1551

Email

mihara-m@saiseikai.gr.jp


Public contact

Name of contact person

1st name Yoshinori
Middle name
Last name Shimizu

Organization

Saiseikai Kawaguchi General Hospital

Division name

Financial and legal department

Zip code

332-8558332-8558

Address

5-11-5 Nishikawaguchi, Kawaguchi-shi, Saitama, Japan

TEL

048-253-1551

Homepage URL


Email

zaimuhoumu@saiseikai.gr.jp


Sponsor or person

Institute

Department of Lymphatic and Reconstructive Surgery, Saiseikai Kawaguchi General Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Dr. Hideki Origasa
Professor of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saiseikai Kawaguchi General Hospital

Address

Nishi-kawaguchi 5-11-5, Kawaguchi-shi, Saitamaken, Japan

Tel

048-253-1551

Email

mihara.plasticsurgery@gmail.com


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

済生会川口総合病院(埼玉県),
富山大学バイオ統計学・臨床疫学講座 折笠秀樹 教授 (富山県)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 01 Day


Related information

URL releasing protocol

https://www.mominoki-shinryosho.jp/cellulitis/evidence/

Publication of results

Unpublished


Result

URL related to results and publications

https://www.mominoki-shinryosho.jp/cellulitis/evidence/

Number of participants that the trial has enrolled

200

Results

Preparing data

Results date posted

2022 Year 09 Month 24 Day

Results Delayed

Delay expected

Results Delay Reason

Preparing data

Date of the first journal publication of results


Baseline Characteristics

Preparing data

Participant flow

Preparing data

Adverse events

Preparing data

Outcome measures

Preparing data

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 12 Month 01 Day

Date of IRB

2016 Year 12 Month 01 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 04 Day

Last modified on

2022 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028909


Research Plan
Registered date File name
2017/01/04 資料3.研究計画書(様式第1号) 170103.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name