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OpenTrials
Completed

NCT Number: NCT06067880

Surgical Intervention and Lymphatic Diseases.

Supermicrosurgical LVA has been proven effective in treating moderate to severe lymphedema, including cases with diffuse dermal backflow (DB) and even severe lymphatic fluid leakage. Therefore, the use of LVA should not be limited to mild lymphedema, and its indications should be expanded to become a primary surgical approach for more severe lymphedema cases. Among all surgical procedures for lymphedema, LVA is the least invasive, allowing for rapid recovery, minimizing the complications, and reducing medical costs.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

About this study

Lymphatic-related diseases such as lymphedema often result from damage to the lymphatic system due to tumor removal and lymph node dissection surgeries, as well as tissue fibrosis caused by post-operative radiation therapy. This can lead to obstruction in the proximal channels of lymphatic flow, resulting in swelling, deformity of the distal limbs, poor wound healing, or cellulitis.

In the case of lymphatic-related diseases like lymphedema, improvement can be achieved through surgical interventions. Surgery can be categorized into physiologic reconstruction and volume reduction procedures. Among them, Supermicrosurgical Lymphaticovenous Anastomosis (LVA) is a form of physiologic reconstruction. LVA involves the separation of lymphatic vessels in the affected limb and their anastomosis with nearby small veins to alleviate limb swelling and reduce the risk of cellulitis. When using lymphaticovenous bypass surgery to treat lymphedema, the ideal scenario is to use veins for anastomosis that do not have venous blood reflux. This is because veins generally have higher blood pressure than lymphatic fluid, and if venous blood flows into the lymphatic vessels over the long term, it can reduce the patency of the lymphaticovenous anastomosis site. The choice of anastomosis technique, based on the size and position of the lymphatic vessels and veins, can also impact the post-operative outcomes. Therefore, factors such as lymphatic vessel size, flow rate, function, vein size, pressure, and the presence of reflux are closely related to the success of lymphaticovenous bypass surgery.

Supermicrosurgical LVA has been proven effective in treating moderate to severe lymphedema, including cases with diffuse dermal backflow (DB) and even severe lymphatic fluid leakage. Therefore, the use of LVA should not be limited to mild lymphedema, and its indications should be expanded to become a primary surgical approach for more severe lymphedema cases. Among all surgical procedures for lymphedema, LVA is the least invasive, allowing for rapid recovery, minimizing the complications, and reducing medical costs.

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 September 1, 2015, to August 31, 2022.

Exclusion criteria

  • Patients under the age of 20.
  • Patients with incomplete medical records.

Treatment and study plan

Cancer-related Unilateral

Other

This group included patients who have used only contraction type LVs.

Normal + Ectasis LVs

Other

This group included patients who had only non- contraction type LVs.

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

Surgical Intervention and Post Operative Improvement in Patients With Lymphatic Diseases.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2023
Registry last updated
Oct 5, 2023

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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