Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.

Phase 1

• Conditions: ymphedema and lymphatic disease

• Registration Number: JPRN-UMIN000022973
• Lead Sponsor: Saiseikai Kawaguchi General Hospital. Department of lymphatic and reconstructive surgery.

Brief Summary

Preparing data

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-01
• Study Completion: 2017-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

none

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We analyze the assesment pre-operation and every 6 month.

Secondary Outcome Measures

Name	Time	Method
Patient chart (name, patient ID, clinical history, pre and postoperative course, limb circumference, tissue stiffness/softmeasure); echogram(especially collecting lymphatic vessels and elastgrraphy), 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.