The Impact of Supermicrosurgery Intervention on Patients with Lower Extremity Lymphedema Using Groin-Only Approach Lymphaticovenous Anastomosis

Completed

• Conditions: Lymphedema; Lymphedema of Leg

• Registration Number: NCT06685926
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

This study employs a propensity score-matched analysis to compare the treatment outcomes, focusing on percentage volume reduction between the conventional multi-incision lymphaticovenous anastomosis (LVA) technique and the novel single groin incision LVA technique in patients with unilateral lower extremity lymphoedema.

Detailed Description

Lymphaticovenous anastomosis (LVA), a surgical technique that connects lymphatic vessels (LVs) to adjacent veins, has demonstrated efficacy in alleviating lymphedema by enabling the drainage of stagnant lymphatic fluid.

Conventional LVA treatment for lower extremity lymphoedema (LEL) has favored distal, multiple incisions in the lower leg due to the denser and more superficial distribution of LVs and recipient veins in the distal regions.

Based on the recent advancement in the understaning of lymphosomes and the role of antegrade lymph flow, a shift to more proximal LVA around the groin region for LEL could be theoretically advantagous, but its clinical efficacy compared to conventional distal LVA remains underexplored.

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2024-09
• Study Completion: 2024-09
• Status Verified: 2024-10
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study First Posted: 2024-11-13
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

• Patients diagnosed with lymphatic-related diseases to the lower extremity
• Patients who is undergoing LVA for unilateral lower-limb lymphedema.

Exclusion Criteria

• Primary lymphedema
• Bilateral lower limb lymphedema
• History of previous treatment for lymphedema (LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure) - Those that were lost to follow-up.
• Patients who recieved both LVA to the groin site and non-groin site.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Volume change after LVA	6 and 12 months	The primary endpoint is limb volume change at 6 and 12 months after intervention, measured using magnetic resonance volumetry.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan