Unique ID issued by UMIN | UMIN000025891 |
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Receipt number | R000029767 |
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 | 2017/02/01 |
Last modified on | 2022/09/24 10:37:12 |
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 | Obstetrics and Gynecology | Plastic surgery |
Not applicable |
Others
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. In this study, we investigate the difference in the effectiveness of end-to-end anastomosis and end-to-side anastomosis in lymph vessel venous anastomosis.
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
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Device,equipment | Maneuver |
Indocyanine green (ICG) lymphography and Lymphatic venous anastomosis(LVA)
Not applicable |
Not applicable |
Male and Female
1) Saitamaken Saiseikai 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.
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
30
1st name | Makoto |
Middle name | |
Last name | Mihara |
Saiseikai Kawaguchi General Hospital
Lymphatic and Reconstructive Surgery
332-8558
5-11-5 Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
048-253-1551
mihara.plasticsurgery@gmail.com
1st name | Yoshinori |
Middle name | |
Last name | Shimizu |
Saiseikai Kawaguchi General Hospital
Financial and legal department
332-8558
5-11-5 Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
048-253-1551
zaimuhoumu@saiseikai.gr.jp
Department of Lymphatic and Reconstructive Surgery, Saiseikai Kawaguchi General Hospital
none
Self funding
Saiseikai Kawaguchi General Hospital
Nishi-kawaguchi 5-11-5, Kawaguchi-shi, Saitamaken, Japan
048-253-1551
zaimuhoumu@saiseikai.gr.jp
NO
済生会川口総合病院(埼玉県)
2017 | Year | 02 | Month | 01 | Day |
https://www.mominoki-shinryosho.jp/cellulitis/evidence/
Unpublished
https://www.mominoki-shinryosho.jp/cellulitis/evidence/
220
Preparing data
2022 | Year | 09 | Month | 24 | Day |
Delay expected |
Preparing data
Preparing data
Preparing data
Preparing data
Preparing data
Completed
2017 | Year | 01 | Month | 29 | Day |
2015 | Year | 01 | Month | 01 | Day |
2017 | Year | 02 | Month | 01 | Day |
2019 | Year | 01 | Month | 31 | Day |
2017 | Year | 01 | Month | 29 | Day |
2022 | Year | 09 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029767
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