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Completed

NCT Number: NCT06249360

Lymphatic System Reflux After Lymphatic Operation

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.

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Veins with reflux

Other

This group included patients who used only recipient veins with reflux

Reflux-free recipient veins

Other

This group included patients who utilized only reflux-free recipient veins

Primary outcomes

  1. Volume change after LVA.

    Time frame: 6/12 months

    The primary endpoint was the volume change at 6/12 months after LVA.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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