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
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
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
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
