LVA on Serum Profiling in Patients With Lymphedema

NCT ID: NCT04552938

Last Updated: 2020-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-11

Study Completion Date

2020-09-11

Brief Summary

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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

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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.

Conditions

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Lymphedema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients underwent supermicrosurgical LVA

Patients underwent supermicrosurgical LVA between June 2018 and May 2019.

pre-LVA

Intervention Type OTHER

Venous serum samples were collected from patients before LVA.

post-LVA

Intervention Type OTHER

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

Interventions

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pre-LVA

Venous serum samples were collected from patients before LVA.

Intervention Type OTHER

post-LVA

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201800306B0

Identifier Type: -

Identifier Source: org_study_id

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