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

RecruitingNAAges 18 Years - anyAllHerlev and Gentofte Hospital
NCT07073586 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-garme

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📋 Eligibility rules (as published)
Inclusion Criteria: * LLL International Society of Lymphology (ISL) stage 1-2a (both primary and secondary lymphedema and both unilateral and bilateral) * Cancer-free with no recurrence for at least one year * Age 18 or above * Circumference of the affected leg is at least 1 cm larger than the non-lymphedema leg at the most affected site of lymphedema. * Proficiency in Danish language, and ability to provide informed consent. * Dermal Backflow Stage 0-4 Exclusion Criteria: * LLL International Society of Lymphology (ISL) stage 2b-3 * Medical conditions contraindicating surgical intervention or anesthesia, such as severe heart or lung disease * Allergy to ICG * Ongoing infections or skin diseases in the affected limb * Previous surgery or other treatment modalities that could interfere with the study results (previous LVA, liposuction or similar). * Dermal Backflow Stage 5 * Active cancer * Heart or kidney conditions that can cause leg swelling * A BMI above 28 kg/m² * Current smoker * Any foreign objects in the lower extremities (e.g., metal implants, prostheses) * Venous insufficiency Unilateral weakness in the lower extremity (e.g., after a stroke) * Known iodine allergy (contraindication for ICG injection) * Leg length discrepancy (anisomelia) \> 1.5 cm
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What it tests

  • Lymphovenous Anastomosis
  • Complete Decongestive Therapy
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Where

2 sites
Department of Plastic Surgery, Odense University Hospital
Odense, Denmark
Department of Plastic Surgery, Herlev and Gentofte Hospital
Herlev, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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