Skip to main content
OpenTrials
Completed

NCT Number: NCT06685926

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema of Leg

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supermicrosurgical LVA, Groin Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis)

Procedure

Supermicrosurgical LVA, Conventional Multiple Access Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis)

Procedure

Primary outcomes

  1. Volume change after LVA

    Time frame: 6 and 12 months

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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Groin-Only Lymphaticovenous Anastomosis for Lower Extremity Lymphoedema: a Retrospective Cohort Propensity-Score Matched Analysis of a Novel Supermicrosurgical Concept

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2024
Registry last updated
Nov 13, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.