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

NCT ID: NCT06685926

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 189 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2024-09-30

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.

Conditions

Lymphedema; Lymphedema of Leg

Study Groups

Groin-Only Approach LVA

This is a group of patients who had a single incision based LVA procedure.

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

Intervention Type: PROCEDURE

Conventional Approach LVA

This is a group of patients who had the conventional LVA approach with multiple incisions for access.

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

Intervention Type: PROCEDURE

Interventions

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

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

202401630B0

Identifier Type: -

Identifier Source: org_study_id