LVA on Serum Profiling in Patients With Lymphedema

Completed

• Conditions: Lymphedema
• Interventions: Other: pre-LVA; Other: post-LVA

• Registration Number: NCT04552938
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Status Verified: 2018-04
• Study Start: 2018-04-11
• Primary Completion: 2020-06-01
• Study Completion: 2020-09-11
• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-16
• Last Update Submitted: 2020-09-16
• Study First Posted: 2020-09-17
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients underwent supermicrosurgical LVA	pre-LVA	Patients underwent supermicrosurgical LVA between June 2018 and May 2019.
Patients underwent supermicrosurgical LVA	post-LVA	Patients underwent supermicrosurgical LVA between June 2018 and May 2019.

Primary Outcome Measures

Name	Time	Method
the correlation between post-LVA volume reduction	6 months after surgery	The primary outcome was determined whether post-LVA volume reduction \< 40%

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan