Effect of Lymphovenous Anastomosis on Lower Limb Lymphedema: Pragmatic Randomized Controlled Trial
Protocol: Effect of Lymphovenous Anastomosis in the Treatment of Lower Limb Lymphedema - Pragmatic Assessor-Blinded Open-Label Randomized Controlled Trial (PrCT)
Herlev and Gentofte Hospital
66 participants
May 9, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria14
- 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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Interventions
Microsurgical creation of multiple lymphatic-venous connections in the most affected limb under general anaesthesia.
Complete Decongestive Therapy, comprising bandaging, skin care and exercise, followed by compression garments.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07073586