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LVA on Serum Profiling in Patients With Lymphedema

The Impact of Lymphaticovenous Anastomosis on Serum Profiling in Patients With Lymphedema

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04552938
Enrollment
26
Registered
2020-09-17
Start date
2018-04-11
Completion date
2020-09-11
Last updated
2020-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

Brief summary

The correlation between oxidative stress and increased lymphedematous limb volume lacks supporting evidence. Lymphedema patients are prone to cellulitis. This study aims to investigate the link between oxidative stress, limb volume, and cellulitis after supermicrosurgical lymphaticovenous anastomosis (LVA).

Detailed description

In this study, we focused on the changes in serum antioxidant biomarkers before and after LVA, detected by isobaric tags for relative and absolute quantitation (iTRAQ)-based quantitative proteomic analysis, enzyme-linked immunosorbent assay (ELISA), and Oxidative Stress Panel Kit. For clinical correlation, magnetic resonance (MR) volumetry was implemented for precise lymphedematous limb volume measurements. Correlations were made between changes in oxidative stress, limb volume, and cellulitis before and after LVA.

Interventions

OTHERpre-LVA

Venous serum samples were collected from patients before LVA.

OTHERpost-LVA

Venous serum samples were collected from patients one-month after LVA.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* patients with lower limb lymphedema confirmed with lymphoscintigraphy * unilateral lower limb lymphedema * lymphedema duration \> 2 years * no active infection * no prophylactic antibiotic use for at least one month before LVA * no tumor recurrence or metastasis * no consumption of antioxidants, such as vitamin E or ascorbic acid

Exclusion criteria

* Patients with upper limb and bilateral lower limb lymphedema

Design outcomes

Primary

MeasureTime frameDescription
the correlation between post-LVA volume reduction6 months after surgeryThe primary outcome was determined whether post-LVA volume reduction \< 40%

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026