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

Sponsor
Herlev and Gentofte Hospital
Study ID
NCT07073586
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lymphovenous Anastomosis — PROCEDURE
    Microsurgical creation of multiple lymphatic-venous connections in the most affected limb under general anaesthesia.
  • Complete Decongestive Therapy — OTHER
    Complete Decongestive Therapy, comprising bandaging, skin care and exercise, followed by compression garments.

Study Details

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.

Key Dates

First listed
Jul 18, 2025
Start date
May 9, 2025
Status verified
Jul 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2029

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lymphovenous anastomosis (LVA) + Compression Therapy
    LVA + conservative care. Patient must have undergone Complete Decongestive Therapy (CDT) and comply with the compression treatment. Follow-up at 6, 12 and 24 months includes blinded assessment of L-Dex, tape and perometry volumes, DXA, lymphoscintigraphy, erysipelas incidence and LYMQOL/EQ-5D-5L scores; patency is checked by ICG-lymphography at 12 months. A subset of 10 patients with unilateral lymphedema also provides paired skin biopsies (both legs) at surgery and again 6 months postoperatively for biomarker and histological analysis.
  • Active Comparator: Compression Therapy Alone
    Conservative care alone. Participants complete standard Complete Decongestive Therapy, comprising bandaging, skin care and exercise, followed by compression garments. Outcomes are assessed by the same blinded schedule as the LVA arm at baseline, 6, 12 and 24 months. Participants may elect LVA crossover after the 12-month evaluation if desired.

Primary Outcome Measure

Change in L-Dex ratio (bioimpedance spectroscopy) at 12 months. [ Time Frame: Baseline to 12 months ]

Central Contacts

Related Studies