Supermicrosurgical Lymphvenous Bypass Intervention for Treatment

February 28, 2022 updated by: Chang Gung Memorial Hospital

Supermicrosurgical Lymphvenous Bypass Intervention for Lymphedema Treatment

Background: In addition to antegrade anastomosis, retrograde anastomosis has been thought to offer further improvements after lymphaticovenous anastomosis (LVA) by bypassing the retrograde lymphatic flow. However, this concept has yet to be validated. The aim of this study was to determine the impacts on outcomes of performing both retrograde and antegrade anastomosis, as compared to antegrade-only anastomosis for treating lower limb lymphedema.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

87

Contacts and Locations

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

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (age > 18 years) with lower limb lymphedema patients were enrolled from March 2016 to December 2020.

Description

Inclusion Criteria:

  • 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 was a retrospective cohort propensity score-matched study. Patients with lower limb lymphedema were enrolled.
Other: Antegrade and retrograde anastomoses
Patients who had received both antegrade and retrograde anastomoses.
Other: Antegrade-only anastomoses
Patients who had received antegrade-only anastomoses.

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 outcome assessments. The primary endpoint was the volume change at 6 months 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)

September 6, 2021

Primary Completion (Anticipated)

August 31, 2022

Study Completion (Anticipated)

September 5, 2022

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202101384B0

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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