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NCT04698707 Clinical Trial

Role of Supermicrosurgical LVA for Lower Limb Lymphedema

Lymphedema Clinical Trial

Official title:
The Role of Supermicrosurgical Lymphaticovenous Anastomosis for Lower Limb Lymphedema - A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04698707
Other study ID # 202001420B0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 28, 2020
Est. completion date November 19, 2020

Study information
Verified date January 2021
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Vascularized lymph node flap transfer (VLNT) was believed to be the treatment of choice for moderate-to-severe lymphedema. Recent publications have supported the use of supermicrosurgical lymphaticovenous anastomosis (LVA) for treating severe lymphedema. This study hypothesizes whether LVA can be performed on post-VLNT patients seeking further improvement.

Recruitment information / eligibility
Status Completed
Enrollment 131
Est. completion date November 19, 2020
Est. primary completion date October 5, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 100 Years
Eligibility Inclusion Criteria: - From November 2014 to January 2019 - Lower limb lymphedema patients Exclusion Criteria: - Patients who have had previous LVA, liposuction, or excisional therapy such as the Charles procedure were excluded.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Vascularized lymph node flap transfer
Patients who have received VLNT as their primary treatment but with minimal improvement
• Patients without prior lymphedema surgery
Patients without prior lymphedema surgery

Locations
Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Magnetic resonance volumetry Magnetic resonance volumetry was used for measuring preoperative and postoperative volume changes at least 6-month after LVA. 6 months after LVA
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