UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025137
Receipt No. R000028909
Scientific Title Lymphatic Venous Anastomosis for Secondary lymphedema.
Date of disclosure of the study information 2017/01/01
Last modified on 2018/02/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Makoto Mihara
Organization Saiseikai Kawaguchi General Hospital
Division name Lymphatic and Reconstructive Surgery
Zip code
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
Middle name
Last name Yoshinori Shimizu
Organization Saiseikai Kawaguchi General Hospital
Division name Financial and legal department
Zip code
Address 5-11-5 Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
TEL 048-253-1551
Homepage URL
Email zaimuhoumu@saiseikai.gr.jp

Sponsor
Institute Department of Lymphatic and Reconstructive Surgery, Saiseikai Kawaguchi General Hospital
Institute
Department

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
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 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
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 No longer recruiting
Date of protocol fixation
2016 Year 12 Month 01 Day
Date of IRB
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
2018 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.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


Contact us.