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NCT06249360 Clinical Trial

Lymphatic System Reflux After Lymphatic Operation

Lymphedema Clinical Trial

Official title:
Influence of Lymphatic System Reflux After Operation in Patients With Lymphatic Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06249360
Other study ID # 202301216B0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date December 30, 2023

Study information
Verified date August 2023
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 79
Est. completion date December 30, 2023
Est. primary completion date November 15, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Veins with reflux
This group included patients who used only recipient veins with reflux
• Reflux-free recipient veins
This group included patients who utilized only reflux-free recipient veins

Locations
Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Volume change after LVA. The primary endpoint was the volume change at 6/12 months after LVA. 6/12 months
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