Unique ID issued by UMIN | UMIN000014748 |
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Receipt number | R000017142 |
Scientific Title | Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease. |
Date of disclosure of the study information | 2014/08/06 |
Last modified on | 2016/01/10 23:01:57 |
Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Japan |
Lymphedema and lymphatic disease
Surgery in general | Vascular surgery | Breast surgery |
Plastic surgery |
Malignancy
NO
Using indocyanine green lymphography to investigate the pathology and the effectiveness of surgical remedies in lymphedema patients by analyzing pre-, intra-, and post-operative lymphatic assessments, comparing pre and postoperative changes, and assessing the associated clinical symptoms.
Efficacy
Confirmatory
Explanatory
Phase I
We analyze the assesment pre-operation and every 6 month. Patient chart (name, patient ID, clinical history, pre and postoperative course, limb circumference, tissue stiffness); echogram, CT, MRI, lymphoscintigraphy, indocyanine green lymphography, and lymphoangiography obervations; blood test (complete blood count, chemistry, coagulation, blood type); histopathological analysis (collecting lymphatic vessel, adipose tissue, skin tissue, etc.); clinical photography (bilateral upper limbs for upper limb edema, bilateral lower limbs, abdominal, and inguinal area for lower limb lymphedema); health-related QOL analysis using Short Form (SF)-36 Health Survey; patient weight; general physical and image observations.
Interventional
Parallel
Non-randomized
Open -no one is blinded
No treatment
3
Treatment
Device,equipment | Maneuver |
Indocyanine green (ICG) lymphography and Lymphatic venous anastomosis(LVA)
Indocyanine green (ICG) lymphography and lymph node transfer
Indocyanine green (ICG) lymphography and liposuction
Not applicable |
Not applicable |
Male and Female
All Subjects included in this study are lymphedema and lymphatic disease patients undergoing surgical treatment at our department who have been fully informed of all clinical tests, questionnaires, surgical treatments, and the purpose and analysis of this study and have all consented in writing. No age restriction and exclusion criteria were set.
none
250
1st name | |
Middle name | |
Last name | Makoto Mihaara |
Saiseikai Kawaguchi General Hospital
Department of Vascular Surgery
5-11-5, Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
048-253-1551
mihara-m@saiseikai.gr.jp
1st name | |
Middle name | |
Last name | Yoshinori Shimizu |
Saiseikai Kawaguchi General Hospital
Financial and legal department
5-11-5 Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
048-253-1551
zaimuhoumu@saiseikai.gr.jp
Saiseikai Kawaguchi General Hospital
none
Self funding
NO
済生会川口総合病院
2014 | Year | 08 | Month | 06 | Day |
Partially published
Total Number of Lymphatic Venous Anastomosis (LVA); 231 cases
Male 14 (6.06%)
Female 217 (94.94%)
General Anesthesia 1 (0.43%)
Local Anesthesia 230 (99.57%)
Upper LVA 8 (3.46%)
Lower LVA 223 (96.54%)
No longer recruiting
2014 | Year | 08 | Month | 06 | Day |
2014 | Year | 08 | Month | 06 | Day |
2014 | Year | 08 | Month | 02 | Day |
2016 | Year | 01 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017142
Research Plan | |
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Registered date | File name |
2014/08/06 | umin140806.5 資料5:本研究の撤回書.pdf |
Research case data specifications | |
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Registered date | File name |
2014/08/06 | 図00.jpg |
Research case data | |
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Registered date | File name |
2016/01/10 | 済生会160110.2 LVA security code multi 前向き検討試験 case list 2015.8.6-2015.8.5.xlsx |