Lymphatic System Reflux After Lymphatic Operation

Completed

• Conditions: Lymphedema
• Interventions: Other: Veins with reflux; Other: Reflux-free recipient veins

• Registration Number: NCT06249360
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

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 Timeline

• Status Verified: 2023-08
• Study Start: 2023-09-01
• Primary Completion: 2023-11-15
• Study Completion: 2023-12-30
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lower Limb Lymphedema	Veins with reflux	Patients with cancer-related unilateral lower limb lymphedema were enrolled.
Lower Limb Lymphedema	Reflux-free recipient veins	Patients with cancer-related unilateral lower limb lymphedema were enrolled.

Primary Outcome Measures

Name	Time	Method
Volume change after LVA.	6/12 months	The primary endpoint was the volume change at 6/12 months after LVA.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan