LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorUniversity Hospital, Ghent

About this trial

Lymphedema is defined as a chronic condition, caused by lymphostasis. A major part in the Western world consists of iatrogenic lymphedema caused by surgery to the lymph nodes of the axilla or groin. Prophylactic lymphovenous anastomosis (LVA) could be beneficial in the prevention of lymphedema of the extremities.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

lymph node + breast cancer requiring dissection

Disqualifiers

previous lymphedema

BMI >35

Trial design

Design model

Parallel

Treatments tested in this trial

  • Axilla dissection + Lymphovenous anastomosis

    Procedure/Surgery

    surgical bypass between lymphatic vessel and vein

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Axilla dissection + Lymphevenous AnastomosisExperimental treatment 1 intervention
Group B: Standard surgeryNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The volume via circumferential measurements: swelling < 5%

Comparing the volume of the arm at each study visit via circumferential measurements: swelling \< 5%

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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