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

NCT06685926 | Completed

• 1 other identifier: 202401630B0
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema; Lymphedema of Leg

Keywords

propensity score matching; LVA; supermicrosurgery; lymphaticovenous anastomosis; lymphovenous bypass

Outcome Measures

Primary Outcomes (1)

• Volume change after LVA

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

  6 and 12 months

Study Arms (2)

Groin-Only Approach LVA

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

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

Conventional Approach LVA

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

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

Interventions

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

Groin-Only Approach LVA

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

Conventional Approach LVA

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 13, 2024
• Study Start: September 1, 2015
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)