A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management

ConditionLymphedema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMemorial Sloan Kettering Cancer Center

About this trial

This study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-80 years

Primary and secondary lymphedema of the upper or lower extremity

International Society of Lymphology (ISL) Stage 1, 2, or 3 lymphedema

Proficiency in English language

Disqualifiers

Patients with clotting disorders, venous insufficiency, end-stage lymphedema unless they are on the non-surgical arm.

Additionally, if the patient refuses to complete questionnaires, the patient will be excluded from the study and replaced at the discretion of the principal or co-principal investigator.

Trial population

Patients who present for consultation of their lymphedema and who meet eligibility criteria will be offered the option of enrolling in this study at the time of their initial consultation.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Quality of Life Assessments

    Behavioral

    Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: vascularized lymph node transfer (VLNT)1 intervention
Group B: non-surgical treatment1 intervention

Trial outcomes

Primary outcomes

1

Quality of Life

Questionnaire to assess quality of life changes

Time frame
up to 40 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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