Protocol: Effect of Lymphovenous Anastomosis in the Treatment of Lower Limb Lymphedema - Pragmatic Assessor-Blinded Open-Label Randomized Controlled Trial (PrCT)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Department of Plastic Surgery, Herlev and Gentofte Hospital
RECRUITING
Herlev
Department of Plastic Surgery, Odense University Hospital
NOT_YET_RECRUITING
Odense
Contact Information
Primary
Amar Bucan, Medical doctor
amar.bucan.02@regionh.dk
+4538685444
Time Frame
Start Date: 2025-05-09
Estimated Completion Date: 2029-08
Participants
Target number of participants: 66
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Herlev and Gentofte Hospital

This content was sourced from clinicaltrials.gov