Clinical Trials Directory

Trials / Completed

CompletedNCT06067880

Surgical Intervention and Lymphatic Diseases.

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

Status
Completed
Phase
Study type
Observational
Enrollment
83 (actual)
Sponsor
Chang Gung Memorial Hospital · Academic / Other
Sex
All
Age
20 Years – 90 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERCancer-related UnilateralThis group included patients who have used only contraction type LVs.
OTHERNormal + Ectasis LVsThis group included patients who had only non- contraction type LVs.

Timeline

Start date
2022-09-23
Primary completion
2023-03-10
Completion
2023-09-01
First posted
2023-10-05
Last updated
2023-10-05

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT06067880. Inclusion in this directory is not an endorsement.