Lymphatic System Reflux After Lymphatic Operation

January 31, 2024 updated by: Chang Gung Memorial Hospital

Influence of Lymphatic System Reflux After Operation in Patients With Lymphatic Disease

This study aimed to determine the impact on outcomes when recipient veins with reflux were used for LVA for the treatment of unilateral lower limb lymphedema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of recipient veins with reflux for lymphaticovenous anastomosis (LVA) is discouraged because of the common belief that it may lead to venous-lymphatic reflux (VLR), a phenomenon in which venous blood is refluxed into the lymphatic lumen after anastomosis, which can lower the long-term patency rate. However, this concept has yet to be validated.

Study Type

Observational

Enrollment (Actual)

79

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All adult patients (age >20 years) receiving LVA for lower limb lymphedema at a tertiary medical center were retrospectively reviewed from October 2015 to December 2022.

Description

Inclusion Criteria:

  • This study including patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from October 1, 2015, to December 31, 2022.
  • Patients who underwent LVA for unilateral lower-limb lymphedema.

Exclusion Criteria:

  • Patients under the age of 20.
  • Patients lost to follow-up or with incomplete data.

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 with cancer-related unilateral lower limb lymphedema were enrolled.
Other: Veins with reflux
This group included patients who used only recipient veins with reflux
Other: Reflux-free recipient veins
This group included patients who utilized only reflux-free recipient veins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume change after LVA.
Time Frame: 6/12 months
The primary endpoint was the volume change at 6/12 months after LVA.
6/12 months

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 1, 2023

Primary Completion (Actual)

November 15, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202301216B0

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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