Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Not Applicable
- Conditions
- ymphedema (especially subclinical and early-stage) and lymphatic disease
- Registration Number
- JPRN-UMIN000019140
- Lead Sponsor
- Saiseikai Kawaguchi General Hospital
- Brief Summary
none
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 234
Inclusion Criteria
Not provided
Exclusion Criteria
none
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Diagnostic imaging for lymph node. And NECST classification for Afferent and Efferent lymph vessels.