Unique ID issued by UMIN | UMIN000019140 |
---|---|
Receipt number | R000022130 |
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 | 2015/09/28 |
Last modified on | 2024/04/09 11:45:22 |
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 (especially subclinical and early-stage) and lymphatic disease
Surgery in general | Vascular surgery | Cardiovascular surgery |
Plastic surgery | Adult | Child |
Others
NO
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.Particularly Assesment of treatment effect about modified Campisi method for subclinical and early-stage lymphedema.
Efficacy
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. We analyze patient pre-operation and every 6 months after operation.
Diagnostic imaging for lymph node. And NECST classification for Afferent and Efferent lymph vessels.
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
3
Treatment
Maneuver |
Indocyanine green (ICG) lymphography and Lymphatic venous anastomosis (Modified Campisi's LVA for subclinical and early-stage lymphedema)
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
100
1st name | makoto |
Middle name | |
Last name | mihara |
Saiseikai Kawaguchi General Hospital
Vascular surgery
3328558
5-11-5, Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
048-253-1551
mihara-m@saiseikai.gr.jp
1st name | Yoshinori |
Middle name | |
Last name | Shimizu |
Saiseikai Kawaguchi General Hospital
Financial and legal department
3328558
5-11-5 Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
048-253-1551
zaimuhoumu@saiseikai.gr.jp
Saiseikai Kawaguchi General Hospital
none
Self funding
none
none
saiseikai kawaguti sogo hospital
nishi-kawagucghi
04288488848
mihara@makoto.fan
NO
済生会川口総合病院(埼玉県)
2015 | Year | 09 | Month | 28 | Day |
https://www.mominoki-shinryosho.jp/cellulitis/evidence/
Unpublished
https://www.mominoki-shinryosho.jp/cellulitis/evidence/
234
none
2024 | Year | 04 | Month | 09 | Day |
none
none
none
none
Main results already published
2015 | Year | 09 | Month | 28 | Day |
2015 | Year | 09 | Month | 01 | Day |
2015 | Year | 10 | Month | 01 | Day |
2017 | Year | 09 | Month | 30 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2015 | Year | 09 | Month | 28 | Day |
2024 | Year | 04 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022130