Role of Supermicrosurgical LVA for Lower Limb Lymphedema

January 5, 2021 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

131

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

From November 2014 to January 2019, a total of 131 lower limb lymphedema patients were enrolled.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
lower limb lymphedema patients
This retrospective cohort study enrolled 131 lower limb lymphedema patients including 10 patients who have received VLNT as their primary lymphedema surgery showing minimal post-VLNT improvement (Group I) and 121 patients without previous lymphatic surgery (Group II).
Other: Vascularized lymph node flap transfer
Patients who have received VLNT as their primary treatment but with minimal improvement
Other: Patients without prior lymphedema surgery
Patients without prior lymphedema surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnetic resonance volumetry
Time Frame: 6 months after LVA
Magnetic resonance volumetry was used for measuring preoperative and postoperative volume changes at least 6-month after LVA.
6 months after LVA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 28, 2020

Primary Completion (ACTUAL)

October 5, 2020

Study Completion (ACTUAL)

November 19, 2020

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (ACTUAL)

January 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202001420B0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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