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

Launched by HERLEV AND GENTOFTE HOSPITAL · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a surgical treatment called lymphovenous anastomosis (LVA) to see if it helps people with lower limb lymphedema—a condition where swelling happens in the legs due to fluid build-up. The trial compares two groups: one group will have the LVA surgery along with regular compression therapy (wearing special garments to reduce swelling), while the other group will continue with compression therapy alone. The study will follow participants for two years to see how well the surgery works in reducing swelling and improving symptoms, using measurements like leg size, infection rates, and patient feedback.

Adults who have mild to moderate leg lymphedema, are cancer-free for at least a year, and have already completed standard swelling treatment are eligible to join. Participants need to speak Danish and be generally healthy enough for surgery. During the study, patients will have regular check-ups to track their progress, and those who don’t have surgery initially can choose to have it after one year if they want. This trial is being done in Denmark and aims to provide clear information on whether LVA surgery is a helpful option for managing leg swelling.

Gender

ALL

Eligibility criteria

• 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