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Effect of Lymphovenous Anastomosis on Lower Limb Lymphedema: Pragmatic Randomized Controlled Trial

NCT07073586 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-07-31

No results posted yet for this study

Summary

This multicentre pragmatic randomised controlled trial evaluates lymphovenous anastomosis (LVA) for lower-limb lymphedema (LLL) in Denmark. Adults with unilateral or bilateral International Society of Lymphology (ISL) stage 1-2a LLL who have completed protocol-defined Complete Decongestive Therapy (CDT) are randomised 1:1 to

Intervention arm - LVA surgery plus ongoing compression care

Control arm - Compression care only

Recruitment takes place at the Departments of Plastic Surgery, Herlev-Gentofte Hospital and Odense University Hospital. Outcomes are assessed by independent blinded staff at baseline, 6, 12 and 24 months. A biopsy substudy in ten LVA patients explores inflammatory and fibrotic changes. Primary endpoint is change in L-Dex ratio at 12 months. Secondary endpoints include limb volume, infection rate, lymphoscintigraphy findings, patient-reported outcomes, compression-garment use and anastomosis patency.

The trial follows Good Clinical Practice and General Data Protection Regulation (GDPR). Patients are covered by the Danish public patient-compensation scheme. Results will be published regardless of outcome, and control participants may opt for LVA after the 12-month visit.

Conditions

  • Lymphedema
  • Lymphoedema
  • Lymphoedema of Leg
  • Lymphedema of Leg

Interventions

PROCEDURE

Lymphovenous Anastomosis

Microsurgical creation of multiple lymphatic-venous connections in the most affected limb under general anaesthesia.

OTHER

Complete Decongestive Therapy

Complete Decongestive Therapy, comprising bandaging, skin care and exercise, followed by compression garments.

Sponsors & Collaborators

  • Herlev and Gentofte Hospital

    lead OTHER

Principal Investigators

  • Lisbet Rosenkrantz Hölmich, MD, Professor, DMSc · Department of Plastic Surgery, Herlev and Gentofte Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-09
Primary Completion
2027-08-31
Completion
2029-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07073586 on ClinicalTrials.gov